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Dockets Management

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Dockets Entered On APril 17, 2006
Docket # Title
1997P-0498 Label foods & beverages containing greater than 5mg caffeine
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
1998P-0724 Prohibition of Cochineal Extract and Carmine Color Additives
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
1999P-1340 Declared Eternity eau de Parfum Misbranded
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2004N-0355 Scientific Considerations Related to Developing Follow-on Protein Products
2004P-0457 Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2005P-0459 To enforce ban on carbon monoxide gas in fresh meat packaging
2006D-0044 Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
2006D-0066 Guidance for Industry and FDA Staff: Whole Grains Label Statements
2006N-0019 Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
2006N-0029 Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Coupons on Consumer Perceptions of Products in Prescription Drugs in Direct-to-Consumer Prescription Drug Prin
2006N-0106 New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition
2006P-0090 Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
1997P-0498 Label foods & beverages containing greater than 5mg caffeine
EMC 7 B. Crum Vol #: 1
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
LET 870 FDA/CFSAN to Natural Factors Nutritional Products Inc Vol #: 26
LET 871 FDA/CFSAN to NuraMD Vol #: 26
LET 872 FDA/CFSAN to Advanced Cardiac Life Sciences LLC Vol #: 26
LET 873 FDA/CFSAN to New Century Company Vol #: 26
LET 874 FDA/CFSAN to Food Science Corporation Vol #: 26
LET 875 FDA/CFSAN to Sedona Laboratories Inc Vol #: 26
1998P-0724 Prohibition of Cochineal Extract and Carmine Color Additives
C 10 L. Oliver Vol #: 1
EMC 23 D. Joyant Vol #: 3
1999N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings
C 18261 B. Martyn Vol #: 516
C 18262 J. Reinhold Vol #: 516
1999P-1340 Declared Eternity eau de Parfum Misbranded
EMC 640 J. Sverdlove Vol #: 24
2000P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
C 12854 B. Martyn Vol #: 806
C 12855 J. Reinhold Vol #: 806
2001P-0345 Listing the color additive yellow #5 for use in food/Drug
EMC 1318 M. King Vol #: 6
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 245 K. Pickens Vol #: 4
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 536 C. Holland, Sr. Vol #: 45
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 632 Calorie COntrol Council Vol #: 9
EMC 633 Mission Possible International Vol #: 9
EMC 634 Mission Possible International Vol #: 9
EMC 635 Mission Possible International Vol #: 9
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1271 P. Eaton Vol #: 12
EMC 1272 P. Eaton Vol #: 12
EMC 1273 E. Sforza Vol #: 12
EMC 1274 D. Buffetta, Jr. Vol #: 12
EMC 1275 J. Schaures Vol #: 12
2004N-0355 Scientific Considerations Related to Developing Follow-on Protein Products
EMC 9 Eli Lilly and Company (Lilly) Vol #: 5
2004P-0457 Reclassifcation of the Buechel-Pappas Unconstrained Ankle Prosthesis
LET 3 HFZ-001 to Endotec, Incorporated Vol #: 2
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
CS 9 HFA-305 Vol #: 3
MO 8 GCF-1 Vol #: 3
OR 9 HF-3 Vol #: 3
2005P-0459 To enforce ban on carbon monoxide gas in fresh meat packaging
C 5 E. Moe Vol #: 2
C 6 Precept Food, LLC Vol #: 2
2006D-0044 Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
C 14 Sanofi-aventis US, Inc. Vol #: 1
C 15 Hoffmann-La Roche, Inc. Vol #: 1
C 16 Society for Clinical Data Management, Inc. (SCDM) Vol #: 1
2006D-0066 Guidance for Industry and FDA Staff: Whole Grains Label Statements
C 6 Whole Grains Council Vol #: 1
C 7 Barilla America, Inc. (Barilla) Vol #: 1
C 8 AmeriFlax Vol #: 1
C 9 Whole Gain Connection Vol #: 1
2006N-0019 Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
C 3 Orthopedic Surgical Maufacturers Association (OSMA) Vol #: 2
2006N-0029 Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Coupons on Consumer Perceptions of Products in Prescription Drugs in Direct-to- Consumer Prescription Drug Prin
C 2 Greenlining Institute Vol #: 1
2006N-0106 New Animal Drugs; Adamantane and Neuraminidase Inhibitor Anti-influenza Drugs; Extralabel Animal Drug Use; Order of Prohibition
EMC 2 American Veterinary Medical Association (AVMA) Vol #: 2
2006P-0090 Immediately begin the phased removal from the market of propoxyphene (Darvon) and all propoxyphene-containing products.
C 1 Xanodyne Pharmaceuticals, Inc. (Xanodyne) Vol #: 1

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