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| Dockets Entered
On October 14, 2005
Table of Contents
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| Docket #
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| Title
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| 1976N-0052G
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| OTC general comments & combinations
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999N-4282
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| Biotechnology in the Year 2000 and Beyond; Public Meetings
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| 1999P-0033
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| Combat the spread of transmissible spongiform encephalopathy
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| 2000D-1598
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| Voluntary Labeling for Bioengineered Foods
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| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
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| 2000P-1211
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| Establish Mandatory Pre-Market Safety Testing for GE Foods
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| 2002D-0018
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| Race and Ethnicity Data in Clinical Trials for FDA
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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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| 2005N-0178
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
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| 2005N-0345
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| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
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| |
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| 2005N-0354
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| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
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| |
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| |
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| 2005N-0404
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| Solicitation of Public Review and Comment on Research Protocol:
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| 2005N-0416
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| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
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| 2005P-0282
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| Require Health Messages on Soft Drinks
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| 2005V-0415
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| performance standard for fluoroscopic equipment mfged by OrthoScan
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| 1976N-0052G
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| OTC general comments & combinations
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|
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| EMC 1
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| S. Pursley
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| Vol #:
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| 35
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| LET
12
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| HFS-800 to Cantox US Inc
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| Vol #:
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| 230
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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| LET
16634
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| Jarrow Formulas
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| Vol #:
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| 149
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| |
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| LET
16635
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| Jarrow Formulas
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| Vol #:
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| 149
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| |
|
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| LET
16636
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| Jarrow Formulas
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| Vol #:
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| 149
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| |
|
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| LET
16637
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| Jarrow Formulas
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| Vol #:
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| 149
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| |
|
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| LET
16638
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| Jarrow Formulas
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| Vol #:
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| 149
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| |
|
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| LET
16639
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| Jarrow Formulas
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| Vol #:
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| 149
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| |
|
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| LET
16640
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| Jarrow Formulas
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| Vol #:
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| 149
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| |
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| LET
16641
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| Jarrow Formulas
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| Vol #:
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| 149
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| |
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| LET
16642
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| Pharmanex, LLC
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| Vol #:
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| 149
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| LET
16643
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| Arkopharma, LLC
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| Vol #:
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| 149
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| |
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| LET
16644
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| Arkopharma, LLC
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| Vol #:
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| 149
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| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| EMC 4224
|
| J. Hudson
|
| Vol #:
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| 515
|
| |
|
|
| 1999P-0033
|
| Combat the spread of transmissible spongiform encephalopathy
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| |
|
|
| EMC 1
|
| Form Letter
|
| Vol #:
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| 10
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| |
|
|
| EMC 2
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| K. Martellaro
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| Vol #:
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| 9
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| |
|
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| EMC 3
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| K. West
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| Vol #:
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| 9
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| |
|
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| EMC 4
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| G. Schlegel
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| Vol #:
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| 9
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| |
|
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| EMC 5
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| L. Walzem
|
| Vol #:
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| 9
|
| |
|
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| 2000D-1598
|
| Voluntary Labeling for Bioengineered Foods
|
| |
|
|
| EMC 12025
|
| B. Gallagher
|
| Vol #:
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| 574
|
| |
|
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| 2000N-1396
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| Bioengineered Foods Consumed By Humans or Animals
|
| |
|
|
| EMC 11594
|
| B. Gallagher
|
| Vol #:
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| 349
|
| |
|
|
| 2000P-1211
|
| Establish Mandatory Pre-Market Safety Testing for GE Foods
|
| |
|
|
| EMC 5840
|
| C. Craig
|
| Vol #:
|
| 789
|
| |
|
|
| EMC
5841
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| Consumers for Dental Choice
|
| Vol #:
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| 789
|
| |
|
|
| EMC 5842
|
| J. Hudson
|
| Vol #:
|
| 789
|
| |
|
|
| 2002D-0018
|
| Race and Ethnicity Data in Clinical Trials for FDA
|
| |
|
|
| EMC 7
|
| B. Sachau
|
| Vol #:
|
| 2
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 1136
|
| I M Lawn
|
| Vol #:
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| 11
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| |
|
|
| EMC 1137
|
| K M Holton
|
| Vol #:
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| 11
|
| |
|
|
| EMC 1138
|
| C R Shamel
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| Vol #:
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| 11
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| |
|
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| 2005N-0178
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
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| |
|
|
| N
2
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| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 2005N-0345
|
| Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
|
| |
|
|
| EMC 185
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| B & J Stanfield
|
| Vol #:
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| 3
|
| |
|
|
| EMC
186
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| Planned Parenthood of the Inland Northwest
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| Vol #:
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| 3
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| |
|
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| EMC
187
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| Planned Parenthood of the Rocky Mountains
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| Vol #:
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| 3
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| |
|
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| EMC 188
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| F Alterton RN
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| Vol #:
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| 3
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| |
|
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| EMC 189
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| N Dallas
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| Vol #:
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| 3
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| |
|
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| EMC
190
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| Planned Parenthood of Central Pennsylvania
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| Vol #:
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| 3
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| |
|
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| EMC
191
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| Northern Adirondack Planned Parenthood
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| Vol #:
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| 3
|
|
| | | | | | | | |
|
| |
|
| 2005N-0354
|
| Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
|
| |
|
|
| APE 1
|
| Alcon Surgical, IOL Marketing
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 158
|
| Walker, Elizabeth
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| Vol #:
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| 2
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| |
|
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| EAPE 159
|
| McLoudrey, Mark
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| Vol #:
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| 2
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| |
|
|
| EAPE 160
|
| Aikin, Kathryn
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| Vol #:
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| 2
|
| |
|
|
| EAPE 161
|
| Wood, Greg
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| Vol #:
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| 2
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| |
|
|
| EAPE 162
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| Davis, Kristin
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| Vol #:
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| 2
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| |
|
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| EAPE 163
|
| Van Syckel, Lisa
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| Vol #:
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| 2
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| |
|
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| EAPE 164
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| Berry, Peggy
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| Vol #:
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| 2
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| |
|
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| EAPE 165
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| Dannemann, Eileen
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| Vol #:
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| 2
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| |
|
|
| EAPE 166
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| Rillo, Julie
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| Vol #:
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| 2
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| |
|
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| EAPE 167
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| Spence, Michele
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| Vol #:
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| 2
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| |
|
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| EAPE 168
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| Vij, Kanika
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| Vol #:
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| 2
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| |
|
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| EAPE 169
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| Cannistraci, David
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| Vol #:
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| 2
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| |
|
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| EAPE 170
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| Benecchi, Chris
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| Vol #:
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| 2
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| |
|
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| EAPE 171
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| Yegen, Chris
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| Vol #:
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| 2
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| |
|
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| EAPE 172
|
| Witczak, Kim
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| Vol #:
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| 2
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| |
|
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| EAPE 173
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| Katz, Daniel
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| Vol #:
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| 2
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| |
|
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| EAPE 174
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| Brooke, Shelagh
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| Vol #:
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| 2
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| |
|
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| EAPE 175
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| Goss, Catherine
|
| Vol #:
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| 2
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| |
|
|
| EAPE 176
|
| Cannistraci, David
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| Vol #:
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| 2
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| |
|
|
| EAPE 177
|
| Gallauresi, Beverly
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| Vol #:
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| 2
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| |
|
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| EAPE 178
|
| Gray, Catherine
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| Vol #:
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| 2
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| |
|
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| EAPE 179
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| Sugerman-Brozan, Alex
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| Vol #:
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| 2
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| |
|
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| EAPE 180
|
| Schwamlein, Anna
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| Vol #:
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| 2
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| |
|
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| EAPE 181
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| Rich, Laura
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| Vol #:
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| 2
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| |
|
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| EAPE 182
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| Rieker, Denise
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| Vol #:
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| 2
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| |
|
|
| EAPE 183
|
| Browning, Crystal
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 184
|
| Liversidge, Ellen
|
| Vol #:
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| 2
|
| |
|
|
| EAPE 185
|
| Zuckerman, Diana
|
| Vol #:
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| 2
|
| |
|
|
| EAPE 186
|
| Klar, Doedy
|
| Vol #:
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| 2
|
| |
|
|
| EAPE 187
|
| Allen, J. Aron
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 188
|
| Bednarz, Bradley
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 189
|
| Jans, Kristin
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 190
|
| McKelvey, Stephen
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 191
|
| Rothkopf, Carol
|
| Vol #:
|
| 2
|
|
| | | | | | | |
| |
|
|
| EAPE 192
|
| Hankin, Joan
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 193
|
| Filmore, David
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 194
|
| Jezarian, Wendy
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 195
|
| Unterreiner, Mark
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 196
|
| Frank, Lesley
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 197
|
| Cobb, Mary
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 198
|
| Day, Ruth
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 199
|
| Rosa, David
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 200
|
| Irons, Lea
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 201
|
| Board Member, AARP
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 202
|
| Ruskin, Gary
|
| Vol #:
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| 2
|
| |
|
|
| EAPE 203
|
| Baylor-Henry, JD, Minnie
|
| Vol #:
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| 2
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| |
|
|
| EAPE 204
|
| Columbia-Walsh, Meg
|
| Vol #:
|
| 2
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| |
|
|
| EAPE 205
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| Carpenter, Charles
|
| Vol #:
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| 2
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| |
|
|
| EAPE 206
|
| Kastner, Kathy
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 207
|
| Bolling, Jay
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 208
|
| Rouleau, Gaetan
|
| Vol #:
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| 2
|
| |
|
|
| EAPE 209
|
| Arent, Jill
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 210
|
| Shaw, Michael
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 211
|
| Arent, JIll
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 212
|
| Pietrowski, Mary
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 213
|
| Board Member, AARP
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 214
|
| Audet, Craig
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 215
|
| Fogarty, Helen
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 216
|
| javitt, gail
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 217
|
| Holdsworth, Stacy
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 218
|
| Brady, Patrick
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 219
|
| Lassman, Scott
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 220
|
| Stein, Gary
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 221
|
| Allison-Ottey, Sharon
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 222
|
| Allison-Ottey, Sharon
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 223
|
| Czeizinger, Andrea
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 224
|
| Burkholder, Rebecca
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 225
|
| Krapf, David
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 226
|
| Graham, Christopher
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 227
|
| Mehta, Abhilasha
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 228
|
| Mehta, Abhilasha
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
| |
|
|
| EAPE 229
|
| Shipley, Russell
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 230
|
| Gardner, James
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 231
|
| Mehta, Abhilasha (Abby)
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 232
|
| Allison-Ottey, Sharon
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 233
|
| Ziltz, Bob
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 234
|
| Schuyler, Suzie
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 235
|
| Sicola, Michelle
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 236
|
| Solomon, Stefanie
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 237
|
| Chon, Jin
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 238
|
| Mayhew, Brian
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 239
|
| Katzin, Lisa
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 240
|
| Allen, Ingrid
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 241
|
| Brachman, Dina
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 242
|
| Machowsky, Martin
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 243
|
| Gilgore, Lance
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 244
|
| Slaughter, Edwin
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 245
|
| Samp, Richard
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 246
|
| Kastner, Kathy
|
| Vol #:
|
| 2
|
| |
|
|
| EAPE 247
|
| walsh, laura
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
4
|
| USRA Respiratory - MIGU -PIE
|
| Vol #:
|
| 2
|
| |
|
|
| EMC
5
|
| Pfizer Inc
|
| Vol #:
|
| 2
|
| |
|
|
| 2005N-0394
|
| FDAs Communication of Drug Safety Information; Public Hearing
|
| |
|
|
| APE 4
|
| APhaRC LLC
|
| Vol #:
|
| 1
|
| |
|
|
| APE 5
|
| Stephen A Goldman Consulting Services LLC
|
| Vol #:
|
| 1
|
| |
|
|
| APE 6
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 3
|
| Berry, Peggy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 4
|
| Van Syckel, Lisa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 5
|
| Van Syckel, Lisa
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 6
|
| Wade, Lindsey
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 7
|
| Zuckerman, Diana
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 8
|
| Frank, Lesley
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 9
|
| Outterson, Kevin
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 10
|
| Downing, Mathy Milling
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 11
|
| Rothkopf, Carol
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 12
|
| Jezarian, Wendy
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 13
|
| Davidson, james H.
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EAPE 14
|
| Pahl, Tish
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 15
|
| Halpern, Naomi
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 16
|
| Balmford, Kathryn
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 17
|
| Edwards, John
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 18
|
| Roberts, Michael
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 19
|
| McNair, Douglas
|
| Vol #:
|
| 1
|
| |
|
|
| EAPE 20
|
| Haughey, David
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0404
|
| Solicitation of Public Review and Comment on Research Protocol:
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| NM
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005N-0416
|
| Food Allergen Labeling Notification (FALN): Extensively Hydrolyzed Casein
|
| |
|
|
| APP 1
|
| Mead Johnson Nutritionals
|
| Vol #:
|
| 1
|
|
| |
|
| 2005P-0282
|
| Require Health Messages on Soft Drinks
|
| |
|
|
| C
20
|
| Community Health Improvement Project (CHIP)
|
| Vol #:
|
| 1
|
| |
|
|
| 2005V-0415
|
| performance standard for fluoroscopic equipment mfged by OrthoScan
|
| |
|
|
| ACK
1
|
| HFA-305 to OrthoScan, Inc.
|
| Vol #:
|
| 1
|
|
|
