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| Dockets Entered
On July 29, 2004
Table of Contents
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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|
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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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|
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| 1998P-0151
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| Introduction Of Downed Cattle Into The Food Supply
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|
|
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| 1999P-2630
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| Establish a Daily Value for "added sugars"
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|
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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|
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| 2000N-1571
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| Enrofloxacin for Poultry: Opportunity for Hearing
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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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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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|
|
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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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| 2003N-0169
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| Dental Amalgam; Request for Information
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|
|
|
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| 2003N-0199
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Importer?s Entry Notice; Extension
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|
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| 2003N-0342
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| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
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| 2004N-0049
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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|
|
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| 2004N-0081
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| BSE Risk Materials in Foods and Cosmetics
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|
|
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| 2004N-0184
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| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
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| 2004N-0257
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| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
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| 2004N-0258
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| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
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| 2004N-0264
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| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
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| 2004P-0339
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| Refuse to file an ANDA for the combination drug amlodipine besylate-benazepril hydrochloride (amlodipine-benazepril)
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT
201
Attachments
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| JNC NutraChem, Inc
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| Vol #:
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| 154
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| RPT
202
Attachments
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| Atlantic Medical Health Care, Inc
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| Vol #:
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| 154
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|
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| RPT
203
Tabs
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| BioAge Pharmaceuticals, Inc
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| Vol #:
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| 155
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| RPT
204
Attachments
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| American Phyto Lab
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| Vol #:
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| 154
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|
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| RPT
205
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| New Century Company
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| Vol #:
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| 154
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|
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| RPT
206
Attachments
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| New Century Company
|
| Vol #:
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| 156
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| RPT
207
Attachment
1-2
Attachments
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| Tsumura USA Inc
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| Vol #:
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| 157
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|
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| RPT
208
Attachments
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| AMT Labs, Inc
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| Vol #:
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| 156
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|
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| RPT
209
Attachments
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| Medipharm USA
|
| Vol #:
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| 158
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|
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| RPT
210
Continued
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| Conseco Sea Buckthorn Co., LTD
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| Vol #:
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| 156
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|
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| RPT
211
Continued
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| Conseco Sea Buckthorn Co., LTD
|
| Vol #:
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| 156
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|
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| RPT
212
Continued
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| Conseco Sea Buckthorn Co., LTD
|
| Vol #:
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| 156
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|
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| RPT
213
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| Omega Bio-Pharma (USA) LLC
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| Vol #:
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| 156
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| RPT
214
Attachments
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| Perrigo Company
|
| Vol #:
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| 159
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|
| | | | | | | | |
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| RPT
215 Attachments
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| David Tolson
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| Vol #:
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| 160
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|
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| RPT
216
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| Neo Kim Chi Inc
|
| Vol #:
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| 156
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|
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| RPT
217
Continued
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| Conesco Sea Buckthorn Co LTD
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| Vol #:
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| 156
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| RPT
218
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| Hoodia Products, LLC
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| Vol #:
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| 156
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| RPT
219
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| Omega- Bio-Pharma (USA) LLC
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| Vol #:
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| 156
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| RPT
220
References
|
| Omega- Bio-Pharma (USA) LLC
|
| Vol #:
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| 156
|
|
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|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
14121
|
| Now Foods
|
| Vol #:
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| 122
|
|
|
|
|
| LET
14122
|
| Solgar Vitamin and Herbs
|
| Vol #:
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| 122
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|
|
|
|
| LET
14123
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| Solgar Vitamin and Herb
|
| Vol #:
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| 122
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|
|
|
|
| LET
14124
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| Now Foods
|
| Vol #:
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| 122
|
|
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|
|
| LET
14125
|
| Nature's Sunshine Products, Inc.
|
| Vol #:
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| 122
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|
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|
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| LET
14126
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| Nutri Granulations
|
| Vol #:
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| 122
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|
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| LET
14127
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| Nutri Granulations
|
| Vol #:
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| 122
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|
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|
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| LET
14128
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| Nutri Granulations
|
| Vol #:
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| 122
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|
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| LET
14129
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| Tabak's Health Products
|
| Vol #:
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| 122
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| LET
14130
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| Wild Oats Markets, Inc.
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| Vol #:
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| 122
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| LET
14131
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| LifeEnhance, Inc.
|
| Vol #:
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| 122
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|
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| LET
14132
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| Inverness Medical Nutritionals Group
|
| Vol #:
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| 122
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| LET
14133
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| Inverness Medical Nutritionals Group
|
| Vol #:
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| 122
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| LET
14134
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| Standard Process Inc.
|
| Vol #:
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| 122
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|
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| LET
14135
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| Enzymatic Therapy
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| Vol #:
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| 122
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|
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| LET
14136
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| Pharmavite LLC
|
| Vol #:
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| 122
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| EMC 4242
|
| H. Chase
|
| Vol #:
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| 304
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
|
|
| EMC 790
|
| S. Harvey
|
| Vol #:
|
| 33
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
|
|
| EMC 191
|
| C. Moslow
|
| Vol #:
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| 2
|
|
|
|
|
| EMC 192
|
| A. Stevens
|
| Vol #:
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| 2
|
|
|
|
|
| EMC 193
|
| A. Heyser
|
| Vol #:
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| 2
|
|
|
|
|
| EMC 194
|
| R. Brinkman
|
| Vol #:
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| 2
|
|
|
|
|
| EMC 195
|
| D. Schiers
|
| Vol #:
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| 2
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
| | | | | | | | |
|
|
|
|
| EXB 396
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
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| EXB 397
|
| Center for Veterinary Medicine
|
| Vol #:
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| 425
|
|
|
|
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| EXB 398
|
| Center for Veterinary Medicine
|
| Vol #:
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| 425
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|
|
|
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| EXB 399
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 400
|
| Center for Veterinary Medicine
|
| Vol #:
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| 425
|
|
|
|
|
| EXB 401
|
| Center for Veterinary Medicine
|
| Vol #:
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| 425
|
|
|
|
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| EXB 402
|
| Center for Veterinary Medicine
|
| Vol #:
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| 425
|
|
|
|
|
| EXB 403
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 404
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 405
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 406
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 407
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 408
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 409
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 410
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 411
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 412
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 413
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 414
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 415
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 416
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 417
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 418
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| EXB 419
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 425
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1242
|
| T. Bowersox
|
| Vol #:
|
| 5
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 183
|
| Plano
|
| Vol #:
|
| 3
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC
351
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 301
|
| C. Naundorf
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 302
|
| No signature
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 303
|
| S. VanRavenswaay
|
| Vol #:
|
| 8
|
|
| | | | | | | | |
|
|
|
|
| EMC 304
|
| L. Humphrey
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 305
|
| D. Shough
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 306
|
| J. Shaffer
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 307
|
| Dr. T. Labuza
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 308
|
| Dr. T. Labuza
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 309
|
| J. Shands
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 310
|
| S. Sjoberg, MS
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 311
|
| K. Pederson
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 312
|
| A. Mukherjee
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 313
|
| A. Mansfield
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 314
|
| D. Belina
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 315
|
| A. Porubcan
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 316
|
| D. Good
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 317
|
| A. Selby
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 318
|
| M. Bonura
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 319
|
| K. Kerr
|
| Vol #:
|
| 8
|
|
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
|
|
|
|
| EMC
227
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
228
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
229
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
230
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
231
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
232
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
233
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
234
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
235
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
236
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003N-0199
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Importer?s Entry Notice; Extension
|
|
|
|
|
| NAL
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| SS
1
|
| Supporting Statement
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0342
|
| Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
|
|
|
|
|
| EMC
4
|
| Pfizer Consumer Healthcare (Pfizer)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
5
|
| Academy of Managed Care Pharmacy (AMCP)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
6
|
| First DataBank (FDB)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
7
|
| Merck & Co., Inc. (Merck)
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
|
|
| EMC
8
|
| AARP
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
9
|
| National Consumers League (NCL)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
10
|
| American Pharmacists Assn
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
11
|
| American Academy of Physician Assistants (AAPA)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
12
|
| National Council on Patient Information and Education (NCPIE)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0049
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
|
|
|
|
|
|
|
|
|
| EMC 1
|
| N. Turner
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0081
|
| BSE Risk Materials in Foods and Cosmetics
|
|
|
|
|
| EMC 2
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0184
|
| Requirements Pertaining to Sampling and Private Laboratories Used in Connection With Importing Food
|
|
|
|
|
| EMC 7
|
| F. Grunder
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0257
|
| Recordkeeping Requirements for Human Food and Cosmetics Manufactured from Processed With, or Otherwise Containing Meterial form Cattle
|
|
|
|
|
| EMC 5
|
| A. Carter
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0258
|
| Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
|
|
|
|
|
| EMC
2
|
| Center for Science in the Public Interest (CSPI)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
3
|
| Safe Tables Our Priority (S.T.O.P.)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
4
|
| International Speciality Supply (ISS)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
5
|
| Canadian Horticultural Council (CHC)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
6
|
| US Apple Assn (USApple)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
7
|
| Canadian Horticultural Council (CHC)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
8
|
| Canadian Horticultural Council (CHC)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
9
|
| Microcide, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
10
|
| United Fresh Fruit and Vegetable Assn (United)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| EMC
15
|
| Baker Commodities, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 16
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0339
|
| Refuse to file an ANDA for the combination drug amlodipine besylate-benazepril hydrochloride (amlodipine-benazepril)
|
|
|
|
|
| ACK 1
|
| HFA-305 to Fommer Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
|
| Fommer Lawrence & Haug LLP
|
| Vol #:
|
| 1
|
|
