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| Dockets Entered
On October 17, 2003
Table of Contents
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|
|
| Docket
#
|
| Title
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|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| 1978N-0301
|
| OTC External Analgesic
Drug Products
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids:
Reports of Adverse Events; Availability
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed
Cattle Into The Food Supply
|
|
|
|
|
| 1999N-4282
|
| Biotechnology in the
Year 2000 and Beyond; Public Meetings
|
|
|
|
|
| 1999P-1340
|
| Declared Eternity eau
de Parfum Misbranded
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value
for "added sugars"
|
|
|
|
|
| 2000N-1484
|
| Safety Reporting Requirements
Human Drug/Biological Products
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive
yellow #5 for use in food/Drug
|
|
|
|
|
| 2002D-0325
|
| Polyvinychloride using
Plasticier di-(2-ethyhexyl)phthalate
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as
a Neurotoxic Drug
|
|
|
|
|
| 2003D-0382
|
| Draft Guidance: Sterile
Drug Products Produced by Aseptic Processing
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans
Fatty Acids in Nutrition Labeling; Consumer research to consider possible
footnote statements
|
|
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug
Initiative
|
|
|
|
|
| 2003P-0278
|
| Regulate recombinant
and any other previously unlicensed endotoxin detection tests for validation,
in-process and finished product endotoxin testing od drugs
|
|
|
|
|
| 2003P-0280
|
| Determine that a recombinanat
endotoxin tests intended for endotoxin testing of human drugs and medical
devices
|
|
|
|
|
| 2003P-0321
|
| Refrain from approving
an Abbreviated New Drug Application (ANDA's) for Riavirin
|
|
|
|
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
|
|
|
|
| ACK
11
|
| HFA-305 to Hawaiian
Tropic
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
16
|
| Hawaiian Tropic
|
| Vol #:
|
| 150
|
|
|
|
|
| 1978N-0301
|
| OTC External Analgesic
Drug Products
|
|
|
|
|
| EMC
1
|
| W.F. Young, Inc. (Young)
|
| Vol #:
|
| 105
|
|
|
|
|
| EMC
2
|
| Chattem, Inc.
|
| Vol #:
|
| 105
|
|
|
|
|
| 1995N-0304
|
| Ephedrine Alkaloids:
Reports of Adverse Events; Availability
|
|
|
|
|
| EMC 922
|
| Shirley Costello
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 923
|
| Bill Lemmons,PMP
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 924
|
| No signature
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 925
|
| No signature
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 926
|
| Deborah Smith
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 927
|
| Julie Clark
|
| Vol #:
|
| 375
|
|
|
|
|
| EMC 928
|
| Lodona Monique
|
| Vol #:
|
| 375
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed
Cattle Into The Food Supply
|
|
|
|
|
| EMC 3768
|
| Ira McEvoy
|
| Vol #:
|
| 281
|
|
| | | | | | | |
|
| |
|
| EMC 3769
|
| Robin Goodman
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3770
|
| Rose Osorio
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3771
|
| Carol Norton-Miller
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3772
|
| Ursula Pelka
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3773
|
| Eileen Kennedy-Beaulieu
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3774
|
| Sandra Ejnes
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3775
|
| Melissa Alford
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3776
|
| John and Mary Quigley
|
| Vol #:
|
| 375
|
| |
|
|
| EMC 3777
|
| Jodi de vries
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3778
|
| Patricia Jordan
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3779
|
| Jelena Boromisa
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3780
|
| Karryn Hart
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3781
|
| Jon Hatanpa
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3782
|
| Terri Harville
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3783
|
| Michelle Lee Rickson
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3784
|
| Kaye Beiswanger
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3785
|
| Arlene Quinn
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3786
|
| Susannah Naglee
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3787
|
| Gwen Harris
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3788
|
| Nancy Zoulalian
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3789
|
| Mary Palisi
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3790
|
| Diana Zelnio
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3791
|
| Marla Rosenberg
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3792
|
| Judith Fish
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3793
|
| Deborah Uhlman
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3794
|
| Charles Alvarez
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3795
|
| Will Turtle, PhD
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3796
|
| No signature
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3797
|
| No signature
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3798
|
| Stephanie Johanna Goldbach
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3799
|
| Shirley Allen
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3800
|
| Sylvia Lewis Gunning
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3801
|
| D.L. Taylor
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3802
|
| Valleri Bellini
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3803
|
| Marcel Sebastian
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3804
|
| R. Reichert
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3805
|
| Teresa Russo
|
| Vol #:
|
| 281
|
|
| | | | | | | | |
|
| |
|
| EMC 3806
|
| Niko Mangelmann
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3807
|
| Leslie Dickinson
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3808
|
| Heiko Schiemann
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3809
|
| Carie McAuliffe
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3810
|
| Patricia Jordan
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3811
|
| N. Lambert
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3812
|
| Heather E. Burns
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3813
|
| J. Arellano
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3814
|
| Angela Vogel
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3815
|
| Raluca Albu
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3816
|
| Gillian Carter
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3817
|
| Amber Hall
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3818
|
| Elizabeth Ungar
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3819
|
| Thomas Jatnieks,DVM
|
| Vol #:
|
| 281
|
| |
|
|
| EMC 3820
|
| Diane Bolman
|
| Vol #:
|
| 281
|
| |
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
| |
|
|
| EMC 4062
|
| Stephanie Phillips
|
| Vol #:
|
| 514
|
| |
|
|
| 1999P-1340
|
| Declared Eternity eau de Parfum Misbranded
|
| |
|
|
| EMC 473
|
| No signature
|
| Vol #:
|
| 21
|
| |
|
|
| EMC 474
|
| Susan and Alan Lindsey
|
| Vol #:
|
| 21
|
| |
|
|
| EMC 475
|
| Richard J. Markiewicz
|
| Vol #:
|
| 21
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| EMC 559
|
| Ellen Wadelton
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 560
|
| Shelly Hicks
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 561
|
| Jessica Caviness
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 562
|
| Jeannie Mims
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 563
|
| David Cayford
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 564
|
| Timothy Lewis
|
| Vol #:
|
| 32
|
| |
|
|
| EMC 565
|
| David Berne
|
| Vol #:
|
| 32
|
| |
|
|
| 2000N-1484
|
| Safety Reporting Requirements Human Drug/Biological Products
|
| |
|
|
| EMC 13
|
| No Signature
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
14
|
| Public Citizen's Health Research Group
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
15
|
| Compressed Gas Assn (CGA)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
16
|
| Health Canada
|
| Vol #:
|
| 5
|
|
| | | | | | | |
|
| |
|
| EMC 17
|
| Bruce M. Psaty, MD, PhD
|
| Vol #:
|
| 5
|
|
| |
|
| EMC
18
|
| Academy of Managed Care Pharmacy (AMCP)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 19
|
| Robert J. Reinhard
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 20
|
| Sandy Swanson
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 21
|
| Vickie D. Armenia MA,MT(ASCP)BB
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 22
|
| Stephen Apfelroth,MD,PhD
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
23
|
| Goldsmith Pharmacovigilance and Systems
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 24
|
| Chuck McGill
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
25
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 26
|
| Number Not Used
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
27
|
| American Assn of Blood Banks (AABB)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
28
|
| LifeGas, Ltd.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
29
|
| San Diego Blood Bank (SDBB)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 30
|
| Bert van Leeuwen, MD
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 31
|
| Kathleen A. Houston, MT(ASCP)SBB
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
32
|
| College of American Pathologists (CAP)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 33
|
| Neil Blumberg, MD
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
34
|
| Mississippi Valley Regional Blood Center
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
35
|
| The European Agency for the Evaluation of Medicinal Products (EMEA)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
36
|
| Quintiles Transnational Corp.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
37
|
| Assn of Clinical Research Organizations (ACRO)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 38
|
| Holli Mason Mathews, MD
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 39
|
| Dale Shoemaker
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 40
|
| Emmett Reilly, MD
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 41
|
| Susan Galel, MD
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
42
|
| Pharmacovigilance & risk Management, Inc.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
43
|
| America Blood Centers (ABC)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 44
|
| Vickie D. Armenia MA,MT(ASCP)BB
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
45
|
| Pfizer, Inc.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
46
|
| Institute for Safe Medication Practices (ISMP)
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
47
|
| Eli Lilly and Company
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
48
Attachment
|
| Baxter Heathcare Corporation
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 49
|
| Judith M. Kramer, MD, MS
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 50
|
| Air Liquide America, L.P.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 51
|
| Sandra Davis
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
52
Attachment
|
| Johnson-Johnson Pharmaceutical Research & Development, LLC
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 53
|
| Paul D. Mintz, MD
|
| Vol #:
|
| 5
|
|
| | | | | | | | |
|
| |
|
| EMC
54
|
| Orion Pharma, Inc.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
55
|
| Air Liquide America, LP
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
56
|
| Blood Systems, Inc.
|
| Vol #:
|
| 5
|
| |
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
| |
|
|
| EMC 1205
|
| No signature
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 1206
|
| Ken Kucera
|
| Vol #:
|
| 5
|
| |
|
|
| 2002D-0325
|
| Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
|
| |
|
|
| EMC 131
|
| M. Gray
|
| Vol #:
|
| 3
|
| |
|
|
| EMC 132
|
| Jennifer Cook
|
| Vol #:
|
| 3
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC 280
|
| Betty Martini
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 281
|
| Betty Martini
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 282
|
| Betty Martini
|
| Vol #:
|
| 5
|
| |
|
|
| 2003D-0382
|
| Draft Guidance: Sterile Drug Products Produced by Aseptic Processing
|
| |
|
|
| EMC
3
|
| Allermed Laboratories, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 87
|
| Albert C. Sears, PhD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 88
|
| Severna Park, MD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 89
|
| David M. Lemon
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 90
|
| Theodore Willmore, MD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 91
|
| Vincent Martin, PhD
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 92
|
| Cynthia Aceves
|
| Vol #:
|
| 1
|
|
| |
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
| |
|
|
| EMC 3
|
| Jay Cobden
|
| Vol #:
|
| 2
|
| |
|
|
| 2003P-0278
|
| Regulate recombinant and any other previously unlicensed endotoxin detection tests for validation, in-process and finished product endotoxin testing od drugs
|
| |
|
|
| EMC
2
|
| Cambrex Bio Science Walkersville
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0280
|
| Determine that a recombinanat endotoxin tests intended for endotoxin testing of human drugs and medical devices
|
| |
|
|
| EMC
2
|
| Cambrex Bio Science Walkersville
|
| Vol #:
|
| 1
|
| |
|
|
| 2003P-0321
|
| Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin
|
| |
|
|
| EMC
81
|
| ICN Pharmacuticals, Inc. and Ribapharm , Inc.
|
| Vol #:
|
| 2
|
|
|
