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| Dockets Entered
On December 9, 2004
Table of Contents
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| Docket #
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| Title
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| 1978N-0348
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| Glycerin; Affirmation of GRAS Status
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| 1978N-1074
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| SPONGE FOR INTERNAL USE
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| 1978N-2670
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| PORCINE BURN DRESSING
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| 1978P-0052
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| FOOD LABELING, EMULSIFIERS & STABILIZERS (CAROB BEAN GUM)
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| 1979N-0095
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| Sodium Dithionite and Zinc Dithionite
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| 1979P-0265
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| EXEMP HOMOEOPATHIC DRUG PROD FROM GMP REGULATIONS
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| 1980N-0148
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| Hydrochloric Acid
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| 1980N-0373
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| CHEESES AND RELATED CHEESE PROD
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| 1980N-0418
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| Deletion of GRAS Status of Caffeine
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| 1981N-0281
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| POLICY FOR REGULATING CARCINOGENIC CHEM IN FOOD & COLOR
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| 1981N-0382
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| Sodium gluconate, zinc gluconate & gluconic acid
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| 1982N-0006
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| Protein Hydrolysates (Milk Casein)
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| 1982N-0219
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| Regenerated Collagen Proposed GRAS Status
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| 1982N-0246
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| Ascorbic Acid and Its Sodium & Calcium Salts
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| 1982N-0318
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| CAFFEINE IN NONALCOHOLIC CARBONATED BEVERAGES
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| 1982N-0389
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| COMMON OR USUAL NAMES FOR DILUTED FRUIT OR VEGETABLE JUIC
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| 1982P-0316
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| Reclassify electroconvulsive therapy (ECT) SECTION 513(E)
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| 1984N-0101
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| NEW DRUG & ANTIBIOTIC APPLICATION REVIEW; USER CHARGE
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| 1984N-0334
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| VINYL CHLORIDE POLYMERS
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| 1984N-0341
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| Unmodified Food Starches and Acid-Modified Starches etc
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| 1985N-0145
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| Use of Acrylonitrile Copolymers
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| 1985N-0241
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| HEMATOLOGY & PATHOLOGY DEV/PMA/AUTOMOTED BLOOD CELL SEPER
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| 1986N-0077
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| NDA'S: PROPOSED CLARIFICATION OF REQUIREMENTS FOR APP
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| 1986N-0445
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| QUALITY STD FOR FOOD WITH NO IDENTITY STD BOTTLED WATER
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| 1986P-0338
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| AMEND STANDARDS OF IDENTITY & QUALITY FOR PINEAPPLE JUICE
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| 1988N-0058
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| New Animal Drug Regulations
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| 1990N-0309
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| Drug Labeling; Sodium Labeling For OTC Drugs
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| 1997N-0484S
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| Human Cellular and Tissue-Based Products
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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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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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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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-0484
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| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
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| 2004N-0204
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| Agency Information Collection Activities; Proposed Collection; Comment Request; , Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Part 60 (21 CFR Part 60)
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| 2004N-0395
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
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| 2004P-0141
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| NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons
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| 2004P-0542
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| Nutrient Content Claims fo Carbohydrates in Food Labeling
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| 1978N-0348
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| Glycerin; Affirmation of GRAS Status
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1978N-1074
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| SPONGE FOR INTERNAL USE
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1978N-2670
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| PORCINE BURN DRESSING
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1978P-0052
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| FOOD LABELING, EMULSIFIERS & STABILIZERS (CAROB BEAN GUM)
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1979N-0095
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| Sodium Dithionite and Zinc Dithionite
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1979P-0265
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| EXEMP HOMOEOPATHIC DRUG PROD FROM GMP REGULATIONS
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1980N-0148
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| Hydrochloric Acid
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1980N-0373
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| CHEESES AND RELATED CHEESE PROD
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1980N-0418
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| Deletion of GRAS Status of Caffeine
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|
|
| NWL
1
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| FDA
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| Vol #:
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| 1
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|
|
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| 1981N-0281
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| POLICY FOR REGULATING CARCINOGENIC CHEM IN FOOD & COLOR
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|
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| NWL
1
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| FDA
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| Vol #:
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| 1
|
|
|
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| 1981N-0382
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| Sodium gluconate, zinc gluconate & gluconic acid
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1982N-0006
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| Protein Hydrolysates (Milk Casein)
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1982N-0219
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| Regenerated Collagen Proposed GRAS Status
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| | | | | | | | |
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1982N-0246
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| Ascorbic Acid and Its Sodium & Calcium Salts
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| |
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| 1982N-0318
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| CAFFEINE IN NONALCOHOLIC CARBONATED BEVERAGES
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1982N-0389
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| COMMON OR USUAL NAMES FOR DILUTED FRUIT OR VEGETABLE JUIC
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| NWL
1
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| FDA
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| Vol #:
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| 4
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|
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| 1982P-0316
|
| Reclassify electroconvulsive therapy (ECT) SECTION 513(E)
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|
|
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| NWL
1
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| FDA
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| Vol #:
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| 35
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| 1984N-0101
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| NEW DRUG & ANTIBIOTIC APPLICATION REVIEW; USER CHARGE
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| NWL
1
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| FDA
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| Vol #:
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| 4
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| 1984N-0334
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| VINYL CHLORIDE POLYMERS
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| NWL
1
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| FDA
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| Vol #:
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| 1
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|
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| 1984N-0341
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| Unmodified Food Starches and Acid-Modified Starches etc
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1985N-0145
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| Use of Acrylonitrile Copolymers
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| |
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| 1985N-0241
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| HEMATOLOGY & PATHOLOGY DEV/PMA/AUTOMOTED BLOOD CELL SEPER
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1986N-0077
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| NDA'S: PROPOSED CLARIFICATION OF REQUIREMENTS FOR APP
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|
|
|
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| NWL
1
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| FDA
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| Vol #:
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| 1
|
|
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| 1986N-0445
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| QUALITY STD FOR FOOD WITH NO IDENTITY STD BOTTLED WATER
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|
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|
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| NWL
1
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| FDA
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| Vol #:
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| 1
|
|
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| 1986P-0338
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| AMEND STANDARDS OF IDENTITY & QUALITY FOR PINEAPPLE JUICE
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1988N-0058
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| New Animal Drug Regulations
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| NWL
1
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| FDA
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| Vol #:
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| 1
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| 1990N-0309
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| Drug Labeling; Sodium Labeling For OTC Drugs
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| EMC 392
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| Dr. J. Bowen
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| Vol #:
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| 7
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| EMC
393
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
394
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
395
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
396
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
397
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
398
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
399
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
400
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
401
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
402
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
403
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
404
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
405
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
406
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| Mission Possible Intl.
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| Vol #:
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| 7
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| EMC
407
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| Mission Possible Intl.
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| Vol #:
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| 7
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| CS
11
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| HFA-305
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| Vol #:
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| 6
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| OR
10
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| HF-3
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| Vol #:
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| 6
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| RBF
1
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| Korangy Radiology Associates, P.A., et al
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| Vol #:
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| 6
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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 477
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| A. Gmurowski
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| Vol #:
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| 9
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| EMC 478
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| G. Piotrowski
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| Vol #:
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| 9
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| EMC 479
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| M. Edwards
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| Vol #:
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| 9
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| EMC 480
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| No signature
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| Vol #:
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| 9
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| EMC 481
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| D. Haskins
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| Vol #:
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| 9
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| EMC 482
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| K. Kouwenhoven
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| Vol #:
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| 9
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| EMC 483
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| D. Stalker
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| Vol #:
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| 9
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| EMC 484
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| S. Lopez
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| Vol #:
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| 9
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| 2004D-0484
|
| Guidance for Industry on the Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
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|
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| GDL
1
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| Guideline
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| Vol #:
|
| 1
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|
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| NAD
1
|
| FDA
|
| Vol #:
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| 1
|
|
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| 2004N-0204
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; , Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Part 60 (21 CFR Part 60)
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