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| Dockets Entered
On January 4, 2006
Table of Contents
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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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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| 2005D-0391
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| Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators
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| 2005N-0394
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| FDAs Communication of Drug Safety Information; Public Hearing
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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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-0420
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| Establish therapeutic equivalence requirements for any generic or following-on drug product referencing Adderall XR MASP
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| 2006P-0001
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| Date of Approval for Lunesta (Eszopiclone) Tablets
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| 2006P-0002
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| Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET
17054
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| Natural Organics Inc.
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| Vol #:
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| 154
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| LET
17055
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| Standard Process Inc.
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| Vol #:
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| 154
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| LET
17056
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| NOW Foods
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| Vol #:
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| 154
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| LET
17057
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| NOW Foods
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| Vol #:
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| 154
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| LET
17058
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| NOW Foods
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| Vol #:
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| 154
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| LET
17059
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17060
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| CocoaLife, LP
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| Vol #:
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| 154
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| LET
17061
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| Enzymatic Therapy
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| Vol #:
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| 154
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| LET
17062
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| Nature's Way Products, Inc.
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| Vol #:
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| 154
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| LET
17063
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| Infinity2 Health Sciences, Inc.
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| Vol #:
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| 154
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| LET
17064
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| IVAX Dermatologicals, Inc.
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| Vol #:
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| 154
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| LET
17065
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| DW Performance Science
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| Vol #:
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| 154
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| LET
17066
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| DW Performance Science
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| Vol #:
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| 154
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| LET
17067
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| DW Performance Science
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| Vol #:
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| 154
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| LET
17068
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| The Daily Wellness Company
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| Vol #:
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| 154
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| LET
17069
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| DW Performance Science
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| Vol #:
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| 154
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| LET
17070
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| DSM Nutritional Products, Inc.
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| Vol #:
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| 154
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| LET
17071
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| Neways International, Inc.
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| Vol #:
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| 154
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| 1997S-0163
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| Dietary Supplements, Courtesy Letters (Letters of Objection)
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| LET
851
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| FDA/CFSAN to New Health Systems, LLC dba Chicken Soup for the Soul Supplements
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| Vol #:
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| 26
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| LET
852
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| FDA/CFSAN to Miracle Breakthrough Labs Inc
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| Vol #:
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| 26
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| LET
853
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| FDA/CFSAN to Gulf Biomedical Corporation
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| Vol #:
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| 26
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| LET
854
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| FDA/CFSAN to New Chapter Inc
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| Vol #:
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| 26
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| LET
855
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| FDA/CFSAN to NOW Foods
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| Vol #:
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| 26
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| 1998D-0266
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| Section 121 Positron Emission Tomography (PET) FDAMA
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| C
19
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| GE Healthcare
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| Vol #:
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| 15
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| C
20
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| Bristol-Myers Squibb Medical Imaging
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| Vol #:
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| 15
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| 2002N-0273
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| Animal Proteins Prohibited in Ruminant Feed
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| C
517
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| Congress of the United States
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| Vol #:
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| 40
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| C
518
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| Congress of the United States
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| Vol #:
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| 40
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| EC
222
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| Mr. Ricky Brunson
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| Vol #:
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| 34
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| EC
223
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| Canadian Meat Council
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| Vol #:
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| 34
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| EC
224
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| Cargill
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| Vol #:
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| 34
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| EC
225
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| Mr. Lincoln Kelley
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| Vol #:
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| 34
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| EC
226
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| National Milk Producers Federation
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| Vol #:
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| 34
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| EC
227
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| Ms. Ken Yonce
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| Vol #:
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| 34
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| EC
228
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| Georgia Department of Agriculture
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| Vol #:
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| 34
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| EC
229
Attachment
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| CA Department of Food and Agriculture
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| Vol #:
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| 34
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| EC
230
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| FOOD ANIMAL CONCERNS TRUST
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| Vol #:
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| 34
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| EC
231
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| Kansas Livestock Association
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| Vol #:
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| 34
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| EC
232
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| Waste Reduction by Waste Redusion, Inc.
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| Vol #:
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| 34
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| EC
233
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| Mr. Burgess Guinn
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| Vol #:
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| 34
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| EC
234
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| Mr. Marc Klocke
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| Vol #:
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| 34
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| EC
235
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| Texas Department of Agriculture
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| Vol #:
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| 34
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| EC
236
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| Georgia Department of Agriculture
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| Vol #:
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| 34
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| EC
237
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| Consumers Union
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| Vol #:
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| 34
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| EC
238
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| Nebraska By-Products, Inc.
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| Vol #:
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| 34
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| EC
239
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| National Meat Association
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| Vol #:
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| 34
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| EC
240
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| Embassy of Japan
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| Vol #:
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| 34
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| EC
241
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| Dr. Anne Fetscher
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| Vol #:
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| 34
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| EC
242
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| Minnesota Department of Agriculture
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| Vol #:
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| 34
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| EC
243
Attachment
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| The Humane Society of the United States
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| Vol #:
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| 34
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| EC
244
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| Scientists
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| Vol #:
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| 34
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| EC
245
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| Simonsen Rendering
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| Vol #:
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| 34
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| EC
246
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| R-CALF USA
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| Vol #:
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| 34
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| EC
247
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| R-CALF USA
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| Vol #:
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| 34
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| EC
248
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| Consumers Union
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| Vol #:
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| 34
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| EC
249
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| Mr. Larry Riggs
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| Vol #:
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| 34
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| EMC
128
Attachment
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| R-CALF USA
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| Vol #:
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| 14
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| EMC
129
Attachment
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| R-CALF USA
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| Vol #:
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| 14
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| EMC
130
Attachment
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| R-CALF USA
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| Vol #:
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| 26
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| 2004N-0439
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| Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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| C
7
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| Bristol-Myers Squibb Medical Imaging
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| Vol #:
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| 1
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| 2004P-0557
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| ANDA for a generic version of Efudex Cream(fluorouracil) cream
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| C
2
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| Rothwell Figg Ernst
& Manbeck
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| Vol #:
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| 3
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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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| C
25
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| Department of Defense, Armed Services Blood Program Office
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| Vol #:
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| 3
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| 2005D-0340
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| Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
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| C
5
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| Galderma Laboratories LP
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| Vol #:
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| 1
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| 2005D-0391
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| Guidance for Industry and Food and Drug Administration Staff; Functional Indications for Implantable Cardioverter Defibrillators
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| C
1
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| Cardiovascular Medicine & Cardiac Arrhythmias
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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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| C
3
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| American Academy of Dermatology Association
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| Vol #:
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| 2
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| 2005P-0305
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| Remove Dietary Supplements that Contain the Drug Pyridoxamine
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| RC
2
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| BioStratum Inc
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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 99
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| J Sisson
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| Vol #:
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| 2
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| C 100
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| D A Jordan
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| Vol #:
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| 2
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| C 101
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| D Carlton
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| Vol #:
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| 2
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| C 102
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| S Heitke
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| Vol #:
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| 2
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| C 103
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| K Murphy
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| Vol #:
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| 2
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| C 104
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| C Dolphin
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| Vol #:
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| 2
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| C 105
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| B Curtiss
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| Vol #:
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| 2
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| C 106
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| B Walker
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| Vol #:
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| 2
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| C 107
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| T Ozdemir
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| Vol #:
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| 2
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| C 108
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| D Anders
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| Vol #:
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| 2
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