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| Dockets Entered
On October 3, 2006
Table of Contents
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| Docket #
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| Title
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| 1976N-0052N
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| OTC Nasal Decongestants
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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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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| 2004P-0351
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| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
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| 2005P-0166
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| to prevent the unlawful misbranding of prescription distance glasses and contact lenses
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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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-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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| 2006E-0008
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| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
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| 2006E-0050
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| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
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| 2006E-0204
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| Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| 2006N-0107
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| FDA-Regulated Products Containing Nanotechnology Materials
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| 2006N-0211
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds
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| 2006N-0219
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| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
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| 2006N-0292
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| Unique Device Identification
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| 2006N-0382
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Postmarket Surveillance
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| 2006P-0090
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| Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
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| 2006P-0151
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| Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants
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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-0403
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| Determine whether an Abbreviated New Drug Application can be filed against the listed drug Novamine 15%, manufactured by Hospira under NDA 17-957
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| 2006P-0404
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| ANDA for Cefotan (cefotetan injection)
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| 1976N-0052N
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| OTC Nasal Decongestants
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| LET 123
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| FDA/CDER to Arnold & Porter, LLP
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| Vol #:
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| 86
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| 1981N-0022
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| OTC Weight Control Drug Products for Human Use
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| LET 117
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| FDA/CDER to Arnold & Porter
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| Vol #:
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| 98
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| 2001P-0345
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| Listing the color additive yellow #5 for use in food/Drug
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| EMC 1332
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| D. Marshall
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| Vol #:
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| 6
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| EMC 172
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| I. Freda
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| Vol #:
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| 14
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| EMC 173
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| M. Parisi
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| Vol #:
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| 14
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| EMC 174
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| V. Lopez
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| Vol #:
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| 14
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| EMC 175
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| R. Warbrick
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| Vol #:
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| 14
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| EMC 176
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| Association of Food & Drug Officials (A. F. D. O.)
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| Vol #:
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| 14
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| EMC 177
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| C. Getz
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| Vol #:
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| 14
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| EMC 178
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| United States Senate
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| Vol #:
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| 14
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| EMC 179
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| A. Hiltz
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| Vol #:
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| 14
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| EMC 180
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| J. Aune
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| Vol #:
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| 14
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 705
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| Mission Possible International
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| Vol #:
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| 10
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| EMC 706
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| J. Hicks
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| Vol #:
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| 10
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| 2003N-0076
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| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
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| EMC 1351
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| C. Lavelle
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| Vol #:
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| 12
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| EMC 1352
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| J. Lynch
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| Vol #:
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| 12
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| EMC 1353
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| J. Creech
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| Vol #:
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| 12
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| EMC 1354
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| J. Wemmer
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| Vol #:
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| 12
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| EMC 1355
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| M. Crites
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| Vol #:
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| 12
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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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| GDL 2
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| Guidance for Industry
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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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| 2004P-0351
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| Change the labeling and take further action to address the association of Viagra (Sildenafil) use and increased STD transmission, including HIV infection
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| PDN 1
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| FDA/CDER to STD Prevention and Control Service
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| Vol #:
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| 1
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| 2005P-0166
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| to prevent the unlawful misbranding of prescription distance glasses and contact lenses
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| EMC 1
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| FDA/CDRH
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| Vol #:
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| 2
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| 2005P-0377
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| Petition to Rescind the "Generally Recognized as Safe" or GRAS Status for Aluminum Based Food Additives
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| SUP 18
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| Department of the Planet Earth
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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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| EMC 3963
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| L. Bianchi
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| Vol #:
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| 195
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| EMC 3964
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| B. Davis
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| Vol #:
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| 195
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| EMC 3965
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| J. Andrews
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| Vol #:
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| 195
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| EMC 3966
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| D. Nelson
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| Vol #:
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| 195
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| EMC 3967
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| C. Watts
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| Vol #:
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| 195
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| EMC 3968
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| L. Scoggins
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| Vol #:
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| 195
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| EMC 3969
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| P. Ault
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| Vol #:
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| 195
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| EMC 3970
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| H. Shirven
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| Vol #:
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| 195
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| EMC 3971
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| J. Nesheim
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| Vol #:
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| 195
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| EMC 3972
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| L. Faber
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| Vol #:
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| 195
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| EMC 3973
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| J. De Roos
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| Vol #:
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| 195
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| EMC 3974
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| T. Hering
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| Vol #:
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| 195
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| EMC 3975
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| M. Pickett
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| Vol #:
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| 195
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| EMC 3976
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| S. Weeks
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| Vol #:
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| 195
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| EMC 3977
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| M. Dolce
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| Vol #:
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| 195
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| EMC 3978
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| S. Brodie
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| Vol #:
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| 195
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| EMC 3979
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| S. Carter
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| Vol #:
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| 195
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| EMC 3980
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| C. Nielson
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| Vol #:
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| 195
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| EMC 3981
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| J. Kroeckel
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| Vol #:
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| 195
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| EMC 3982
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| S. Burch
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| Vol #:
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| 195
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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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| C 6
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| National Organization for Rare Disorders, Inc. (NORD)
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| Vol #:
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| 2
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| 2006E-0008
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| Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006E-0050
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| Patent Extension Application for BYETTA (exenatide injection), U.S. Patent No. 5,424,286
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006E-0204
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| Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923
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| N 1
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| FDA
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| Vol #:
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| 1
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| 2006N-0067
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| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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| NEC 1
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| FDA
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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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| C 10
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| T. Lee
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| Vol #:
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| 1
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| C 11
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| H. Sharp
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| Vol #:
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| 1
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| 2006N-0211
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds
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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-0219
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| Clinical Trial Design Issues in the Development of Products for Treatment of Chronic Hepatitis C Infection
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| | | | | | | | |
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| EC 1
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| Hep. C Caring Ambassadors Program
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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 24
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| Mr. Jay Wigley
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| Vol #:
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| 1
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| 2006N-0352
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| Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
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| EC 69
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| Ms. Joanne Laabs
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| Vol #:
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| 3
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| EMC 342
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| J. Fazio
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| Vol #:
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| 6
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| EMC 343
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| J. Fazio
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| Vol #:
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| 6
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| EMC 344
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| J. Hughes
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| Vol #:
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| 6
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| EMC 345
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| C. Brown
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| Vol #:
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| 6
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| EMC 346
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| C. Brown
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| Vol #:
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| 6
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| EMC 347
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| C. Brown
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| Vol #:
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| 6
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| EMC 348
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| C. Brown
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| Vol #:
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| 6
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| EMC 349
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 350
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 351
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 352
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 353
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 354
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 355
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 356
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 357
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| Consumers for Dental Choice
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| Vol #:
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| 6
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| EMC 358
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| G. Tistaert
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| Vol #:
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| 6
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| EMC 359
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| D. Khalsa
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| Vol #:
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| 6
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| EMC 360
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| C. Traywick
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| Vol #:
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| 6
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| EMC 361
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| E. Bowron
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| Vol #:
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| 6
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| EMC 362
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| D. Hanisch
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| Vol #:
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| 6
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| EMC 363
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| G. Gordon
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| Vol #:
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| 6
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| EMC 364
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| P. Windham
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| Vol #:
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| 6
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| EMC 365
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| P. Windham
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| Vol #:
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| 6
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| EMC 366
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| P. Windham
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| Vol #:
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| 6
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| EMC 367
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| Mercury Awareness Alliance
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| Vol #:
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| 6
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| EMC 368
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| L. Harkness
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| Vol #:
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| 6
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| EMC 369
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| West Chester University
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| Vol #:
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| 6
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| EMC 370
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| G. Dice
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| Vol #:
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| 6
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| EMC 371
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| E. Bundy
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| Vol #:
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| 6
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