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| Dockets Entered
On May 3, 2004
Table of Contents
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| Docket
#
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| Title
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| 1997D-0530
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| Use of IEC 60601 Standards;
Medical Electrical;
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| 1997S-0162
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| 30-Day Structure Function Claim
Notification Letters Dietary
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| 1999D-2335
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| Guidance for Medical Gloves
A workshop Manual
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| 1999N-0193
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| Supplements and Other
Changes to an Approved Application
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| 2000D-1350
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| Combined Oral Contraceptives/Labeling/Healthcare
Providers
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| 2001P-0075
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| Switch Status of Emergency Contraceptives
from Rx to OTC
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| 2002N-0276
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| Bioterrorism Preparedness; Registration
of Food Facilities
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| 2002N-0278
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| Bioterrorism; Prior Notice of
Imported Food Shipments
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| 2003D-0570
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| Draft on the Clinical Evaluation
of Weight-Control Drugs
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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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| 2003N-0312
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| Discussion of Animal Feed Safety
System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture
and Distribution of Animal Feeds
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| 2003P-0555
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| Maintain the Electroconvulsive
Therapy Device in Class III for All Indications
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| 2004D-0042
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| Guidances for Industry on Improving
Direct-to-Consumer Advertising for Medical Products
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| 2004D-0065
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| Guidance for Industry:
Prior Notice of Imported Food Questions and Answers
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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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| 2004N-0087
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| Request for Comment on Generic
Drug Issues
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| 2004N-0115
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| Prescription Drug Importation
Study
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| 2004N-0185
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| Agency Information
Collection Activities: Proposed Collection; Comment Request; Animal
Drug User Fee Cover Sheet
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| 2004N-0186
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| Agency Information
Collection Activities: Proposed Collection; Comment Request; Animal
Drug User Fees and Fee Waivers and Reductions
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| 2004P-0206
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| Abbreviated New Drug Application
(ANDA) for Fluticasone Propionate Nasel Spray
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| 2004S-0170
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| Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest
Priority Topics for Research
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| 1997D-0530
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| Use of IEC 60601
Standards; Medical Electrical;
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| EC 3
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| Registered Nurse Consultant
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| Vol #:
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| 1
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| 1997S-0162
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| 30-Day Structure
Function Claim Notification Letters Dietary
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| LET
13844
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| Highland Laboratories
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| Vol #:
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| 117
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| LET
13845
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| Michael's Naturopathic
Programs
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| Vol #:
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| 117
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| LET
13846
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| Gaia Herbs
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| Vol #:
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| 117
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| LET
13847
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| EuroPharma, Inc.
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| Vol #:
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| 117
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| LET
13848
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| EuroPharma, Inc.
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| Vol #:
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| 117
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| LET
13849
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| EuroPharma, Inc.
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| Vol #:
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| 117
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| LET
13850
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| EuroPharma, Inc.
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| Vol #:
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| 117
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| LET
13851
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| Twin Laboratories,
Inc.
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| Vol #:
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| 117
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| LET
13852
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| Twin Laboratories
Inc.
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| Vol #:
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| 117
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| LET
13853
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| Twin Laboratories
Inc.
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| Vol #:
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| 117
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| LET
13854
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| Twin Laboratories
Inc.
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| Vol #:
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| 117
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| LET
13855
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| Enzymatic Therapy
Natural Medicines
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| Vol #:
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| 117
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| LET
13856
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| Enzymatic Therapy
Natural Medicines
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| Vol #:
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| 117
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| LET
13857
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| Enzymatic Therapy
Natural Medicines
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| Vol #:
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| 118
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| LET
13858
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| PhytoPharmica Natural
Medicines
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| Vol #:
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| 118
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| LET
13859
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| PhytoPharmica Natural
Medicines
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| Vol #:
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| 118
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| LET
13860
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| PhytoPharmica Natural
Medicines
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| Vol #:
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| 118
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| LET
13861
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| PhytoPharmica Natural
Medicines
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| Vol #:
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| 118
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| 1999D-2335
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| Guidance for Medical
Gloves A workshop Manual
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| EC 2
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| Mr. Jerome Goldenberg
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| Vol #:
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| 2
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| EC
3
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| AmeriHealthTree, Inc.
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| Vol #:
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| 2
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| 1999N-0193
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| Supplements and
Other Changes to an Approved Application
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| NAL
1
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| FDA
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| Vol #:
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| 5
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| | | | | | | | |
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| EC 356
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| UniGroup Worldwide UTS
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| Vol #:
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| 20
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| EC 395
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| Payne Transportation Inc
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| Vol #:
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| 22
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| EC 396
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| Miss. barb sachau
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| Vol #:
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| 22
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| EC 397
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| Praxair Canada Inc
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| Vol #:
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| 22
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| EC 398
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| Les Jardins Paul Cousineau & Fils inc.
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| Vol #:
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| 22
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| EC 399
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| Les Jardins Paul Cousineau & Fils inc.
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| Vol #:
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| 22
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| EC 400
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| The Norfolk Fruit Growers' Association
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| Vol #:
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| 22
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| EC 401
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| UPS Supply Chain Solutions, Inc.
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| Vol #:
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| 22
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| EC 402
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| UPS Supply Chain Solutions, Inc.
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| Vol #:
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| 22
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| 2003D-0570
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| Draft on the Clinical Evaluation of Weight-Control Drugs
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| EC 4
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| Amylin Pharmaceuticals, Inc.
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| Vol #:
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| 1
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| |
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| 2003H-0432
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| Civil Money Penalty, Korangy Radiology Associates, PA
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| MO
8
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| GCF-1
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| Vol #:
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| 2
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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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| EC 26
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| Mr. Kirk Scarborough
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| Vol #:
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| 7
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| EC
27
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| American Bakers Association
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| Vol #:
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| 7
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| EC
28
Attachment
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| American Bakers Association
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| Vol #:
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| 7
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| 2003N-0312
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| Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
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| EC 5
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| Mr. Don Gilman
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| Vol #:
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| 4
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| EC 6
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| transport marchessault inc
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| Vol #:
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| 4
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| 2003N-0539
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| Over-the-Counter Drug Products; Safety and Efficacy Review
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| EC 3
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| Mr. vimal barot
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| Vol #:
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| 1
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| 2003P-0555
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| Maintain the Electroconvulsive Therapy Device in Class III for All Indications
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| EC 19
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| World association of Electroshock Survivors
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| Vol #:
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| 2
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| 2004D-0041
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| Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Content of Labeling
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| EC 5
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| Mr. kenneth winsett
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| Vol #:
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| 1
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| 2004D-0042
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| Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products
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| EC 3
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| American College of Nurse Practitioners
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| Vol #:
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| 1
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| 2004D-0065
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| Guidance for Industry: Prior Notice of Imported Food Questions and Answers
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| GDL
1
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| Guidance
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| Vol #:
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| 1
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| | | | | | | | |
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| 2004N-0087
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| Request for Comment on Generic Drug Issues
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| EC 1
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| Generic Pharmaceutical Association
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| Vol #:
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| 1
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| 2004N-0115
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| Prescription Drug Importation Study
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| EC 29
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| Ms. Catherine Benavidez RN,MS,Np
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| Vol #:
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| 3
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| EC
30
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| Kidney Cancer Association
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| Vol #:
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| 3
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| EC
31
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| Kidney Cancer Association
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| Vol #:
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| 3
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| EC 32
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| Mr. michael meyer
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| Vol #:
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| 3
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| 2004N-0133
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| Part 11, Electronic Record; Electronic Signatures; Public Meeting
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| EC 1
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| Mr. Michael Bartlett
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| Vol #:
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| 1
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| EC 2
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| Mr. Kai-Erik Uleberg
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| Vol #:
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| 1
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| 2004N-0185
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet
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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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| 2004N-0186
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions
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| N
1
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| FDA
|
| Vol #:
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| 1
|
|
| |
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| 2004P-0206
|
| Abbreviated New Drug Application (ANDA) for Fluticasone Propionate Nasel Spray
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| ACK 1
|
| HFA-305 to Bell, Boyd & LLOYD LLC
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| Vol #:
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| 1
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| CP
1
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| Bell, Boyd & LLOYD LLC
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| Vol #:
|
| 1
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|
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| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
|
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| EC 3
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| University of Colorado Health Sciences Center
|
| Vol #:
|
| 1
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| EC 4
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| Health
|
| Vol #:
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| 1
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| EC 5
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| National Association of Hispanic Nurses/ Colorado
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| Vol #:
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| 1
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