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Dockets Management
Dockets Entered On November 16, 2005
Table of Contents
Docket # Title
1995S-0158 Community Disclosure of Institutional Review Boards
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1999P-5106 Identify Sources of Natural Flavorings
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-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
2004P-0223 Whole Grain Descriptive Claims
2005M-0454 P980022/S011 - Guardian RT
2005N-0317 Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
2005P-0116 To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
2005P-0196 Discontinued Formulation of Pantoprazole Sodium Injection
2005P-0433 Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
2005P-0463 requesting that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act
2005P-0465 Withdraw Draft Regulation on Mercury Amalgam
2005V-0461 Laser Light Show
1995S-0158 Community Disclosure of Institutional Review Boards
SUP 45
Attachment
Northfield Laboratories Inc BB IND 10719 Vol #: 49
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 16877 Avon Products, Inc. Vol #: 152
LET 16878 Doctor's Best, Inc. Vol #: 152
LET 16879 Doctor's Best, Inc. Vol #: 152
LET 16880 Origins Nautral Resources, Inc. Vol #: 152
LET 16881 Nature's Way Products, Inc. Vol #: 152
LET 16882 Perrigo Company of South Carolina Vol #: 152
LET 16883 Perrigo Company of South Carolina Vol #: 152
LET 16884 Perrigo Company of South Carolina Vol #: 152
LET 16885 Perrigo Company of South Carolina Vol #: 152
LET 16886 Perrigo Company of South Carolina Vol #: 152
LET 16887 Perrigo Company of South Carolina Vol #: 152
LET 16888 Perrigo Company of South Carolina Vol #: 152
LET 16889 Amrita Veda Vol #: 152
LET 16890 Enzymatic Therapy Vol #: 152
LET 16891 Harmonic Innerprizes Vol #: 152
LET 16892 Iovate Health Science U.S.A., Inc. Vol #: 152
LET 16893 American Healing Technologies,Inc. Vol #: 152
LET 16894 American Healing Technologies, Inc. Vol #: 152
LET 16895 American Healing Technologies, Inc. Vol #: 152
LET 16896 American Healing Technologies, Inc. Vol #: 152
LET 16897 Enzymatic Therapy Vol #: 152
1999P-5106 Identify Sources of Natural Flavorings
EMC 214 J. Kogen Vol #: 3
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
C 59 B. Gorman Vol #: 4
C 60 K. Long Vol #: 4
C 61 R. Hinthorne Vol #: 4
C 62 B. Cameron Vol #: 4
C 63 E. Pelroy Vol #: 4
C 64 J. Trammell Vol #: 4
C 65 R. Graham Vol #: 4
C 66 A. Chekhun Vol #: 4
C 67 W. Matre Vol #: 4
C 68 M. Izuchukul Vol #: 4
C 69 A. Andreoli Vol #: 4
C 70 C. Williams Vol #: 4
C 71 J. Harger Vol #: 4
C 72 P. Meyer Vol #: 4
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 549 Mission Possible International Vol #: 8
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EMC 1158 L. Savageino Vol #: 11
2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
EMC 1 S. Girvin Vol #: 1
2004P-0223 Whole Grain Descriptive Claims
PDN 1 HFC-1 to Patton Boggs LLP Vol #: 5
2005M-0454 P980022/S011 - Guardian RT
AAV 1 Medtronic MiniMed Vol #: 1
2005N-0317 Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
EMC 1 B. Sachau Vol #: 1
2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
C 488 C. Knop Vol #: 165
C 489 Women's Bar Association of the State of New York (WBASNY) Vol #: 165
EMC 452 P. Pettee Vol #: 33
EMC 453 D. Lucca Vol #: 33
EMC 454 P. Fleming, MD Vol #: 33
EMC 455 N. Feng Vol #: 33
EMC 456 J. Monaghan Vol #: 33
EMC 457 D. Cohen, MD Vol #: 33
EMC 458 J. Karpinsky Vol #: 33
EMC 459 D. Hamilton Vol #: 33
EMC 460 NARAL Pro-Choice America Vol #: 33
EMC 461 J. Melenger Vol #: 33
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
EMC 66 B. Dole Vol #: 4
EMC 67 S. Schultz Vol #: 4
EMC 68 W. Bell Vol #: 4
EMC 69 A. Cassels Vol #: 4
EMC 70 T. Wagoner Vol #: 4
EMC 71 J. Harding Vol #: 4
EMC 72 R. Beltramini Vol #: 4
2005P-0116 To take the following actions with regard to aqueous-based drugs for inhalation that has been compounded by pharmacy operations
C 6 L. Smith Vol #: 2
C 7 M. Reinke Vol #: 2
2005P-0196 Discontinued Formulation of Pantoprazole Sodium Injection
LET 1 HFD-005 to AAC Consulting Group Vol #: 2
2005P-0433 Adoption of Harmonization Policy by the U.S. Codex Delegation and US Policy in harmony with DSHEA and 19 U.S.C. 3512
C 2 J. Machado Vol #: 1
2005P-0463 requesting that the Commissioner of Food and Drugs recommend scheduling of tramadol under the Controlled Substances Act
ACK 1 HFA-305 to Rosei Rocha-Judd Vol #: 1
CP 1
Attachment
Rosei Rocha-Judd Vol #: 1
2005P-0465 Withdraw Draft Regulation on Mercury Amalgam
ACK 1 HFA-305 to Consumers for Dental Choice Vol #: 1
CP 1 Consumers for Dental Choice Vol #: 1
2005V-0461 Laser Light Show
ACK 1 HFA-305 to New Orleans City Park Inprovement Association Vol #: 1
VAR 1 New Orleans City Park Inprovement Association Vol #: 1

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