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| Dockets Entered
On April 18, 2005
Table of Contents
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| Docket #
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| Title
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| 1978N-0064
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| OTC Antiperspirant
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| 1981N-0033P
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| Antigingivitis & Antiplaque-Related Claims
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| 1982N-0166
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| OTC Drug Products for Overindulgence of Alcohol
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| 1985V-0189
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| Laser Light Show
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| 1985V-0340
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| Laser media model LMS
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| 1994D-0025
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| Interim GDL/Labeling Milk & Milk Products from Cows w/rbST
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| 1995V-0231
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| Laser Light Show
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1999E-5116
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| Patent Extension: Xoponex, levalbuterol hcl, #5,362,755
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| 1999P-1340
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| Declared Eternity eau de Parfum Misbranded
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| 1999P-5106
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| Identify Sources of Natural Flavorings
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| 1999V-0185
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| Variance Laser Light Show LT-1000
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| 2000N-0504
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| Egg Safety Action Plan
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| 2000N-1596
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| Uniform Compliance Date for Food Labeling Regulations
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| 2001N-0548
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| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
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| 2001P-0075
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| Switch Status of Emergency Contraceptives from Rx to OTC
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| 2001V-0110
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| Laser Light Show
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| 2002D-0325
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| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
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| 2002N-0278
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| Bioterrorism; Prior Notice of Imported Food Shipments
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| 2002P-0317
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| Recall Aspartame as a Neurotoxic Drug
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| 2002V-0132
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| Laser Light Show
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| 2002V-0240
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| Laser Light Show
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| 2003F-0088
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| Increase the Maximum Permitted Energy Level of X-rays
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| 2003F-0471
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| Filing of Food Additive Petition (FAP 3A4749)
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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-0400
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| Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
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| 2003P-0362
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| Over-the-counter Hearing Aids
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| 2004N-0456
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| Serving Sizes of Products that Can Reasonably be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
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| 2004N-0463
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| Food Labeling: Prominence of Calories
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| 2004N-0541
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
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| 2004N-0565
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| Agency Information Collection Activities; Proposed Collection;
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| 2004P-0015
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| Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
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| 2004P-0105
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| Nutrient Content Claim: Total Carbohydrate Content of Foods
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| 2004P-0171
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| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
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| 2004Q-0151
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| Qualified Health Claim (QHC): soy protein and cancer
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| 2004Q-0201
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| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
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| | | | | | | | |
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| 2005D-0022
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| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
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| 2005N-0032
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| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified Foods and Thermally Processed Lo
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| 2005N-0120
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| Agency Information Collection Activities: Proposed Collection; Comment Request;
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| 2005N-0124
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| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of
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| 2005V-0152
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| Laser Light Show
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|
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| 1978N-0064
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| OTC Antiperspirant
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| C
54
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| Cosmetic, Toiletry and Fragrance Association (CTFA)
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| Vol #:
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| 53
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| C
55
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| Numark Laboratories, Inc.
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| Vol #:
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| 53
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| 1981N-0033P
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| Antigingivitis & Antiplaque-Related Claims
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| ANS
1
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| HFD-560 to Colgate-Palmolive Company
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| Vol #:
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| 86
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| 1982N-0166
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| OTC Drug Products for Overindulgence of Alcohol
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| C
18
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| Procter & Gamble Company
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| Vol #:
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| 26
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| 1985V-0189
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| Laser Light Show
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|
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|
| VRA
13
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| HFZ-300 to Todd Rogers dba Beamin Lasers
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| Vol #:
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| 1
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| 1985V-0340
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| Laser media model LMS
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| VRA
7
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| HFZ-340 to Peachtree Laser Inc.
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| Vol #:
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| 1
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|
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|
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| 1994D-0025
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| Interim GDL/Labeling Milk & Milk Products from Cows w/rbST
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| EMC 1
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| R and L Kenyon
|
| Vol #:
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| 116
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| 1995V-0231
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| Laser Light Show
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| VRA
7
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| HFZ-300 to Production Design International., Inc.
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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
15978
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| Hillestad Pharmaceuitcals
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| Vol #:
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| 141
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| LET
15979
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| Hillestad Pharmaceuitcals
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| Vol #:
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| 141
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| LET
15980
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| Hillestad Pharmaceuitcals
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| Vol #:
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| 141
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|
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| LET
15981
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| Hillestad Pharmaceuitcals
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| Vol #:
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| 141
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| LET
15982
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| Hillestad Pharmaceuitcals
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| Vol #:
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| 141
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| LET
15983
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| Hillestad Pharmaceuitcals
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| Vol #:
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| 141
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| LET
15984
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| Hillestad Pharmaceuitcals
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| Vol #:
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| 141
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| LET
15985
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| Hillestad Pharmaceuitcals
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| Vol #:
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| 141
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|
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| LET
15986
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| Enzymatic Therapy
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| Vol #:
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| 141
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| | | | | | | | |
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| LET
15987
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| Perrigo Company of South Carolina
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| Vol #:
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| 141
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|
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|
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| LET
15988
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| Perrigo Company of South Carolina
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| Vol #:
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| 141
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|
|
|
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| LET
15989
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| Enzymatic Therapy
|
| Vol #:
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| 141
|
|
| |
|
| 1999E-5116
|
| Patent Extension: Xoponex, levalbuterol hcl, #5,362,755
|
|
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
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| 1
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
|
|
|
|
| EMC 596
|
| No signature
|
| Vol #:
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| 24
|
|
|
|
|
| EMC 597
|
| T. Chansky, PhD
|
| Vol #:
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| 24
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|
|
|
|
| EMC 598
|
| T. Chansky, PhD
|
| Vol #:
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| 24
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
|
|
|
|
| EMC 211
|
| P. McKeon
|
| Vol #:
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| 3
|
|
|
|
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| 1999V-0185
|
| Variance Laser Light Show LT-1000
|
|
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|
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| VRA
3
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| HFZ-300 to Nu-Salt Laser
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| Vol #:
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| 1
|
|
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| 2000N-0504
|
| Egg Safety Action Plan
|
|
|
| EMC 1906
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| S. Kelly
|
| Vol #:
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| 31
|
|
|
|
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| 2000N-1596
|
| Uniform Compliance Date for Food Labeling Regulations
|
|
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|
|
| EMC 2
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| E. Curry
|
| Vol #:
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| 1
|
|
|
|
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| 2001N-0548
|
| Guidelines for Voluntary Nutrition Labeling of Raw Fruits
|
|
|
|
|
| EMC 10
|
| R. Broussard
|
| Vol #:
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| 1
|
|
|
|
|
| EMC 11
|
| B. Sachau
|
| Vol #:
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| 1
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| C 2084
|
| B. McCall
|
| Vol #:
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| 300
|
|
|
|
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| C 2085
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| J. Trazino
|
| Vol #:
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| 300
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|
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| EMC 14383
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| G. Lampman
|
| Vol #:
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| 342
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|
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|
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| EMC 14384
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| N. Hays
|
| Vol #:
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| 342
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|
|
|
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| EMC 14385
|
| K. Sample
|
| Vol #:
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| 342
|
|
|
|
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| EMC 14386
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| D. Rodgers
|
| Vol #:
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| 342
|
|
|
|
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| EMC 14387
|
| K. Jordan
|
| Vol #:
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| 342
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|
|
|
|
| EMC 14388
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| J. Allen
|
| Vol #:
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| 342
|
|
|
|
|
| EMC 14389
|
| K. Walters
|
| Vol #:
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| 342
|
|
|
|
|
| EMC 14390
|
| M. Klein
|
| Vol #:
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| 342
|
|
|
|
|
| EMC 14391
|
| E. Peskin
|
| Vol #:
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| 342
|
|
| | | | | | | | |
|
| |
|
| 2001V-0110
|
| Laser Light Show
|
|
|
|
|
| VRA
3
|
| HFZ-300 to OmniSistem Light and Effects
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| EMC 211
|
| S. Langenbahn
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 212
|
| G. Scharf
|
| Vol #:
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| 4
|
|
|
|
|
| EMC 213
|
| H. Matter
|
| Vol #:
|
| 4
|
|
|
|
|
| EMC 214
|
| Y. Carrington
|
| Vol #:
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| 4
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| EMC
228
Attachment
|
| Montreal, Maine & Atlantic Railway Limited et al
|
| Vol #:
|
| 30
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC
451
|
| Calorie Control Council
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC
452
|
| Calorie Control Council
|
| Vol #:
|
| 7
|
|
|
|
|
| 2002V-0132
|
| Laser Light Show
|
|
|
|
|
| VRA
2
|
| HFZ-300 to Sound Dimensions
|
| Vol #:
|
| 1
|
|
|
|
|
| 2002V-0240
|
| Laser Light Show
|
|
|
|
|
| VRA
3
|
| HFZ-300 to Lazerus Laser Systems
|
| Vol #:
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| 1
|
|
|
|
|
| 2003F-0088
|
| Increase the Maximum Permitted Energy Level of X-rays
|
|
|
|
|
| EMC 424
|
| L. Curtis
|
| Vol #:
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| 4
|
|
|
|
|
| 2003F-0471
|
| Filing of Food Additive Petition (FAP 3A4749)
|
|
|
|
|
| EMC 1
|
| B. Sachau
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 718
|
| R. Morris
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 719
|
| No signature
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 720
|
| G. Oliver
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 721
|
| No signature
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 722
|
| J. Preston
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 723
|
| V. Dean
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 724
|
| J. Timmerman
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 725
|
| F. Horwitz
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 726
|
| N. Christian
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 727
|
| S. Reece
|
| Vol #:
|
| 9
|
|
|
|
|
| EMC 728
|
| Anthony
|
| Vol #:
|
| 9
|
|
| | | | | | | | |
|
|
|
|
| EMC 384
|
| M.Brown
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 385
|
| J. McMahon
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 386
|
| A. Kolker
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 387
|
| L. Collier
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 388
|
| A. Traudt
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 389
|
| A. Traudt
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 390
|
| D. Scheikart
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 391
|
| K. McKenna
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC 392
|
| C. Stewart
|
| Vol #:
|
| 3
|
|
|
|
|
| EMC
393
|
| Fallon Community Health Plan
|
| Vol #:
|
| 3
|
|
|
|
|
| 2004N-0463
|
| Food Labeling: Prominence of Calories
|
|
|
|
|
| C 8
|
| Mrs. A. Presley
|
| Vol #:
|
| 1
|
|
|
|
|
| C 9
|
| T. Hammer
|
| Vol #:
|
| 1
|
|
|
|
|
| C 10
|
| J. E. Kloster
|
| Vol #:
|
| 1
|
|
|
|
|
| C 11
|
| S. A. Roman
|
| Vol #:
|
| 1
|
|
|
|
|
| C 12
|
| S. V. Hymowitz
|
| Vol #:
|
| 1
|
|
|
|
|
| C 13
|
| D. Douglass
|
| Vol #:
|
| 1
|
|
|
|
|
| C 14
|
| Mrs. D. A. Maller
|
| Vol #:
|
| 1
|
|
|
|
|
| C 15
|
| T. Kaeff
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0541
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0565
|
| Agency Information Collection Activities; Proposed Collection;
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0015
|
| Deny approval of any New Drug Application ( NDA ) for recombinant salmon calcitonin (rsCT ) nasal spray
|
|
|
|
|
| EMC
2
Attachment
|
| Unigene Laboratories, Inc. (Unigene)
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0105
|
| Nutrient Content Claim: Total Carbohydrate Content of Foods
|
|
|
|
|
| LET
5
|
| Kraft Foods Global Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0171
|
| Standards for 'Similarity' or 'Sameness' of Biotechnology-Derived Products
|
|
|
|
|
| EMC
5
|
| Novo Nordisk Inc
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004Q-0151
|
| Qualified Health Claim (QHC): soy protein and cancer
|
|
|
|
|
| C 69
|
| M. Hughes
|
| Vol #:
|
| 9
|
|
|
|
|
| C 70
|
| A. H. Stewart
|
| Vol #:
|
| 9
|
|
| | | | | | | | |
|
|
|
|
| EMC 326
|
| J. Wines
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 327
|
| T. Vanethu
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 328
|
| B. Williams-Sheng
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC
329
|
| BodyMind Therapy, Inc.
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC
330
|
| Weston A. Price Foundation
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 331
|
| B. Robertson
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC
332
|
| Mirador Research, LLC
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 333
|
| L. McKevitt
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 334
|
| G. Hernesmaa
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 335
|
| E. Wolter
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 336
|
| G. Hernesmaa
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 337
|
| D. Jarrold
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 338
|
| G. Hernesmaa
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 339
|
| V. A. James
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 340
|
| A. Dotcheva
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 341
|
| S. Ansel
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 342
|
| S. Ansel
|
| Vol #:
|
| 7
|
|
|
|
|
| EMC 343
|
| L. Maurer
|
| Vol #:
|
| 7
|
|
|
|
|
| 2004Q-0201
|
| Qualified Health Claim (QHC): Lycopene, Tomatoes and Various Cancers
|
|
|
|
|
| LET
4
|
| H J Heinz Company
|
| Vol #:
|
| 16
|
|
|
|
|
| 2005D-0022
|
| International Conference on Harmonisation; Draft Guidance on S8 Immunotoxicity Studies for Human Pharmaceuticals
|
|
|
|
|
| EMC
2
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
3
|
| Merck & Co., Inc
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
4
|
| Amgen
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0032
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified Foods and Thermally Processed Lo
|
|
|
|
|
|
|
|
|
| N
2
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0120
|
| Agency Information Collection Activities: Proposed Collection; Comment Request;
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005N-0124
|
| Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of
|
|
|
|
|
|
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2005V-0152
|
| Laser Light Show
|
|
|
|
|
| ACK
1
|
| HFA-305 to Insight Technology Incorporated
|
| Vol #:
|
| 1
|
|
