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| Dockets Entered
On December 22, 2005
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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| 1995P-0246
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| Regulatory Action to Prohibit Misleading Food Labeling
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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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-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004P-0329
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| Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
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| 2005D-0274
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| Draft Voluntary Hazard Analysis and Critical Control Point (HACCP) Manuals for Operators and Regulators of Retail and Food Service Establishments
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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005N-0486
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey
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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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| 2005P-0502
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| 513 (e) Reclassification petition for the digital mammography devices
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| 1976N-0052N
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| OTC Nasal Decongestants
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| BKG
4
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| References 1 - 15
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| 35
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| NPR
4
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| FDA
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| Vol #:
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| 35
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| 1995P-0246
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| Regulatory Action to Prohibit Misleading Food Labeling
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| C
447
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| Center for Science in the Public Interest (CSPI)
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| Vol #:
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| 30
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| EC
6
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| Mayo Clinic
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| Vol #:
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| 15
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| EC
7
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| American Pharmacists Association
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| Vol #:
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| 15
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| EC
8
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| Academy of Molecular Imaging
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| Vol #:
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| 15
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| 2000P-0586
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| Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz
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| C 75
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| No signature
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| Vol #:
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| 2
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| 2000P-1491
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| Amend Definition & Standard of Identy for Parmesan Cheese
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| C
2
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| DairiConcepts, L.P.
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| Vol #:
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| 1
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| C
3
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| Consorzio del Formaggio Parmigiano-Reggiano
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| Vol #:
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| 1
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| EXT
1
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| National Center for Standards and Certification Imnformation
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| Vol #:
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| 1
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C
454
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| United States Animal Health Association (USAHA)
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| Vol #:
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| 39
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| C
455
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| Australian Government
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| Vol #:
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| 39
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| C 456
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| R. Moore et al.
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| Vol #:
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| 39
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| C
457
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| Kentucky Farm Bureau Federation
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| Vol #:
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| 39
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| C
458
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| Baker Commodities, Inc.
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| Vol #:
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| 39
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| C
459
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| Farmers Union Industries, LLC
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| Vol #:
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| 39
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| C 460
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| B. Smith
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| Vol #:
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| 39
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| C
461
Attachment
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| National Renderers Association, Inc. (NRA)
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| Vol #:
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| 39
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| EC
197
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| PARAMORE MEAT PROCESSING
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| Vol #:
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| 34
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| EC
198
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| Center for Food Safety
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| Vol #:
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| 34
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| EC
199
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| Pennsylvania Department of Agriculture
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| Vol #:
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| 34
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| EC
200
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| Tennessee Department of Agriculture, animal health
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| Vol #:
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| 34
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| EC
201
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| APC, Inc.
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| Vol #:
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| 34
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| EC
202
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| N. Amer. Spray Dried Blood
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| Vol #:
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| 34
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| EC
203
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| McDonald's Restaurants Corporation
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| Vol #:
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| 34
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| EC
204
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| Mrs. Bonnie Warner
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| Vol #:
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| 34
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| EC
205
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| McDonald's Restaurants Corp
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| Vol #:
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| 34
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| EC
206
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| Dr. Farris Beasley
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| Vol #:
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| 34
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| EC
207
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| Kentucky Department of Agriculture
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| Vol #:
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| 34
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| EC
208
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| American Farm Bureau Federation
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| Vol #:
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| 34
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| EC
209
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| VA Department of Environmental Quality
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| Vol #:
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| 34
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| EC
210
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| The National Assn of State Depts of Agriculture
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| Vol #:
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| 34
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| EC
211
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| Food
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| Vol #:
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| 34
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| EC
212
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| Mrs. melissa cave
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| Vol #:
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| 34
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| EC
213
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| Tennessee Farm Bureau Federation
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| Vol #:
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| 34
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| EC
214
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| Marshall County Farm Bureau
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| Vol #:
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| 34
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| EC
215
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| Giles County Farm Bureau
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| Vol #:
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| 34
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| EC
216
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| South Dakota Animal Industry Board
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| Vol #:
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| 34
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| EC
217
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| Texas and Southwestern Cattle Raisers Association
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| Vol #:
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| 34
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| EC
218
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| Dr. John Eckman
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| Vol #:
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| 34
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| EC
219
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| Clemson University
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| Vol #:
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| 34
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| EC
220
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| American Meat Institute
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| Vol #:
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| 34
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| EC
221
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| Carolina By Products
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| Vol #:
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| 34
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| EMC 124
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| J. Jones
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| Vol #:
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| 14
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| EMC 125
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| L. Cunningham
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| Vol #:
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| 14
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| EMC
126
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| National Grain and Feed Association (NGFA)
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| Vol #:
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| 14
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| |
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| EMC 575
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 576
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 577
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 578
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| Mission Possible International
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| Vol #:
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| 8
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| EMC 579
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| Mission Possible International
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| Vol #:
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| 8
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| EMC
580
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| Calorie Control Council
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| Vol #:
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| 8
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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 1178
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| No signature
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| Vol #:
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| 12
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| EMC 1179
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| No signature
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| Vol #:
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| 12
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| 2004D-0555
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| Class II Special Controls Draft Guidance; Labeling for Male Condoms Made of Natural Rubber Latex
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|
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| EC
2
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| none
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| Vol #:
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| 1
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| 2004H-0322
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| Civil Money Penalty Re: Ecumed Health Group, Inc.
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| CS 19
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| HFA-305
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| Vol #:
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| 10
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| CS 20
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| HF-3
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| Vol #:
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| 10
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| SET 2
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| GCF-1
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| Vol #:
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| 10
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| SET 3
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| GCF-1
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| Vol #:
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| 10
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| SET 4
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| HF-3
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| Vol #:
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| 10
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| SET 5
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| HF-3
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| Vol #:
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| 10
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| |
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| EC
6
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| Mayo Clinic
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| Vol #:
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| 1
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| EC
7
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| Academy of Molecular Imaging
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| Vol #:
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| 1
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| EC
8
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| Academy of Molecular Imaging
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| Vol #:
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| 1
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| EMC 318
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| N. Kulakow
|
| Vol #:
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| 3
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| 2004P-0329
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| Request Public Hearings regarding the sales, distribution and use of hand-held Doppler fetoscopes
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| BKG 1
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| References 1 - 5
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| Vol #:
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| 1
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| NM
1
|
| FDA
|
| Vol #:
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| 1
|
|
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| 2005D-0274
|
| Draft Voluntary Hazard Analysis and Critical Control Point (HACCP) Manuals for Operators and Regulators of Retail and Food Service Establishments
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|
| | | | | | | | |
|
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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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| 2005D-0330
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| Guidance for Industry and FDA Review Staff on Collection of Platelets by Automated Methods
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| EC
4
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| Bergen Community Regional Blood Center
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| Vol #:
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| 3
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|
| |
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| EC
6
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| Connetics
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| Vol #:
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| 1
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| EMC
7
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| Association of American Medical Colleges (AAMC)
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| Vol #:
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| 3
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| 2005N-0486
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| Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey
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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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| 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
12
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| International Academy of Compounding Pharmacists (IACP)
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| Vol #:
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| 1
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| EC
28
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| National Consumers League
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| Vol #:
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| 1
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| 2005P-0502
|
| 513 (e) Reclassification petition for the digital mammography devices
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| ACK 1
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| HFA-305 to Planmed Oy
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| Vol #:
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| 1
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