| | | | | | | | | | |
| |
|
|
| Dockets Entered
On May 14, 2004
Table of Contents
|
|
|
|
|
|
|
| |
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| 2004P-0003
|
| Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
|
| |
|
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
| |
|
|
| 1978N-0038
|
| Sunscreen Drug Products
|
| |
|
|
| LET
179
|
| HFD-560 to Tanning Research Laboratoreis Inc
|
| Vol #:
|
| 150
|
| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
| |
|
|
| EMC 752
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 753
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 754
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 755
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 756
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 757
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 758
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 759
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 760
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 761
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 762
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 763
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 764
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 765
|
| Number Not Used
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 766
|
| Rachel Dean
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 767
|
| Matan Shelomi
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 768
|
| Louise Aubin
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 769
|
| Patrick McMahon
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 770
|
| Gabriel Strout
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 771
|
| Margaret Sutton
|
| Vol #:
|
| 271
|
| |
|
|
| EMC 772
|
| Joshua Heffron
|
| Vol #:
|
| 271
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EC 742
|
| Mr. Alexis Salcedo
|
| Vol #:
|
| 163
|
| |
|
|
| EC 743
|
| Mrs. Patricia Day
|
| Vol #:
|
| 163
|
|
| | | | | | | |
| |
|
|
| EC 744
|
| Catholic church
|
| Vol #:
|
| 163
|
| |
|
|
| EC 745
|
| Catholic church
|
| Vol #:
|
| 163
|
| |
|
|
| EC 746
|
| Dr. David Haas
|
| Vol #:
|
| 163
|
| |
|
|
| EC 747
|
| Ms. Patricia Bernstein
|
| Vol #:
|
| 163
|
| |
|
|
| EC 748
|
| Dr. Robert Jacobson
|
| Vol #:
|
| 163
|
| |
|
|
| EC 749
|
| Miss. Carmen von Rohr
|
| Vol #:
|
| 163
|
| |
|
|
| EC 750
|
| Dr. Jon Brodziak
|
| Vol #:
|
| 163
|
| |
|
|
| EC 751
|
| Mrs. Megan Morell
|
| Vol #:
|
| 163
|
| |
|
|
| EC 752
|
| Ms. M Clade
|
| Vol #:
|
| 163
|
| |
|
|
| EC 753
|
| Mrs. Linda Young
|
| Vol #:
|
| 163
|
| |
|
|
| EC 754
|
| aspen medical group
|
| Vol #:
|
| 163
|
| |
|
|
| EC 755
|
| Ms. John Farhar
|
| Vol #:
|
| 163
|
| |
|
|
| EC 756
|
| none
|
| Vol #:
|
| 163
|
| |
|
|
| EC 757
|
| Mrs. Elaine Harrington
|
| Vol #:
|
| 163
|
| |
|
|
| EC 758
|
| Women's Health Nurse Practitioner
|
| Vol #:
|
| 163
|
| |
|
|
| EC 759
|
| Ms. Kristen Hammond
|
| Vol #:
|
| 163
|
| |
|
|
| EC 760
|
| Ms. Linda Coughlin
|
| Vol #:
|
| 163
|
| |
|
|
| EC 761
|
| Temple University School of Medicine
|
| Vol #:
|
| 163
|
| |
|
|
| EC 762
|
| Emory University
|
| Vol #:
|
| 163
|
| |
|
|
| EC 763
|
| CONCERNED PARENT
|
| Vol #:
|
| 163
|
| |
|
|
| EMC 6624
|
| C. Swadley
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6625
|
| A .R. Pappas
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6626
|
| B. Talyn
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6627
|
| P. R. Hopkins
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6628
|
| J. Morrison
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6629
|
| J. Jameson
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6630
|
| M. Reily
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6631
|
| Diana Clark
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6632
|
| C. Simmons
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6633
|
| E . B. Apana
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6634
|
| N. Partika
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6635
|
| T. Bagby
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6636
|
| M. Simon
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6637
|
| J. Inczauskis
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6638
|
| M.Nyffeler
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6639
|
| K. Swartz
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6640
|
| A. Rogers
|
| Vol #:
|
| 235
|
|
| | | | | | | |
| |
|
|
| EMC 6641
|
| M. Macdonald
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6642
|
| M. Miller
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6643
|
| B. Palmer-Welsh
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6644
|
| S. Frankel
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6645
|
| R. Mangione
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6646
|
| E. Lundquist
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6647
|
| M. Maier
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6648
|
| L. Wilder
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6649
|
| B. Davidson-Miles
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6650
|
| V. Reinstein
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6651
|
| Li. Berhard
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6652
|
| C. M. Wilhelm
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6653
|
| M. Padilla
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6654
|
| Charlene Flowers
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6655
|
| S. Loria
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6656
|
| E. Albanese
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6657
|
| J. E. Barker
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6658
|
| K. McConnell
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6659
|
| K. Abraham
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6660
|
| M. M. Greenbaum
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6661
|
| Marla Sutherland
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6662
|
| L. Sutherland
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6663
|
| D. Johnson
|
| Vol #:
|
| 253
|
| |
|
|
| EMC 6664
|
| P. Epsyein
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6665
|
| V. Valle
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6666
|
| B. Marquez
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6667
|
| K. Gibson, Md, MPH
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6668
|
| S. Maliga
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6669
|
| L. Cooper
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6670
|
| P. Jacob
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6671
|
| Paulette R.
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6672
|
| A. Mclean
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6673
|
| M. Schindler
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6674
|
| A. Wells
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6675
|
| A. S. Hill
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6676
|
| A. Delray
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6677
|
| M. Shapiro
|
| Vol #:
|
| 235
|
|
| | | | | | | |
| |
|
|
| EMC 6678
|
| Dolores Boutin
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6679
|
| John Yep
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6680
|
| Kira Murdock
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6681
|
| A. Hesselrode
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6682
|
| Anne Etges
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6683
|
| L. Jouthas
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6684
|
| J. V. B. Cauffield
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6685
|
| J. W. Nelson
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6686
|
| J. Ratledge
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6687
|
| Lori Levit
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6688
|
| B & M kozi
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6689
|
| R. M. Olivo
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6690
|
| T. Moore
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6691
|
| S. G. Meng
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6692
|
| J. C. Yarger
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6693
|
| C. Soffar
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6694
|
| S. Joffe
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6695
|
| N. Knisley
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6696
|
| D. Curry
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6697
|
| E. Kapp
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6698
|
| M. Tremaglio
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6699
|
| Tamera Trexler
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6700
|
| T. Trexler
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6701
|
| A. F. Twine
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6702
|
| C. V. Cohn
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6703
|
| J. Leonard
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6704
|
| D. G. Croft
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6705
|
| H. Berthoud
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6706
|
| L. Tanaka
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6707
|
| A.Bates
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6708
|
| A. Nishimoto
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6709
|
| J. Battcher- Malchow
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6710
|
| Theodora Haughton
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6711
|
| A. Marra
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6712
|
| E. Sorensen
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6713
|
| G. T. Burda
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6714
|
| Jnana Hand
|
| Vol #:
|
| 235
|
|
| | | | | | | | |
| |
|
|
| EMC 6715
|
| R. Mahajan
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6716
|
| L. Posegay
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6717
|
| Jamie Stutzenburg
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6718
|
| M. Westervelt
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6719
|
| J. Falk
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6720
|
| E. Drey
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6721
|
| D. F. Wells
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6722
|
| N. Eldred
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6723
|
| K . Boland
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6724
|
| R. Villarias, CNM
|
| Vol #:
|
| 235
|
| |
|
|
| EMC 6725
|
| P. Morrison
|
| Vol #:
|
| 234
|
| |
|
|
| EMC 6726
|
| C. Gilles
|
| Vol #:
|
| 235
|
| |
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
| |
|
|
| TS 43
|
| Mark Barondess
|
| Vol #:
|
| 9
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| APE 16
|
| Apotex Inc, ETobicoke
|
| Vol #:
|
| 1
|
| |
|
|
| APE 17
|
| Hollis Group Inc
|
| Vol #:
|
| 1
|
| |
|
|
| APE 18
|
| Ofni Systems Inc
|
| Vol #:
|
| 1
|
| |
|
|
| APE 19
|
| EduQuest
|
| Vol #:
|
| 1
|
| |
|
|
| APE 20
|
| Eli Lilly and Company
|
| Vol #:
|
| 1
|
| |
|
|
| APE 21
|
| GXP International
|
| Vol #:
|
| 1
|
| |
|
|
| APE 22
|
| META Solutions, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| APE 23
|
| Invivodata, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
|
| Genzyme corporation
|
| Vol #:
|
| 1
|
| |
|
|
| C
3
|
| Aventis Pharmaceuticals Inc
|
| Vol #:
|
| 1
|
| |
|
|
| C
4
|
| Animal Health Institute
|
| Vol #:
|
| 1
|
| |
|
|
| C
5
|
| American Red Cross
|
| Vol #:
|
| 1
|
| |
|
|
| EC 5
|
| Mr. Jeff Ralston
|
| Vol #:
|
| 1
|
| |
|
|
| EC 6
|
| Apotex Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 7
|
| EduQuest, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 8
|
| American National Red Cross
|
| Vol #:
|
| 1
|
| |
|
|
| EC 9
|
| The American National Red Cross
|
| Vol #:
|
| 1
|
| |
|
|
| EC 10
|
| GEREQ
|
| Vol #:
|
| 1
|
| |
|
|
| EC 11
|
| BusinessEdge Solutions
|
| Vol #:
|
| 1
|
| |
|
|
| EC 12
|
| BuinessEdge Solutions
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
| |
|
|
| EMC 2
|
| B Hogle
|
| Vol #:
|
| 1
|
|
| |
|
| EMC
3
|
| National Food Processors Association
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
4
|
| Altana Pharma AG
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
5
|
| Sanofi-Synthelabo
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
6
|
| Phase Forward
|
| Vol #:
|
| 1
|
| |
|
|
| LET 1
|
| Wimmer Systems, Inc
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0003
|
| Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
|
| |
|
|
| ACK 3
|
| HFA-305 to Bill Pierson
|
| Vol #:
|
| 1
|
| |
|
|
| PSA 2
|
| Bill Pierson
|
| Vol #:
|
| 1
|
| |
|
|
| 2004S-0170
|
| Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
|
| |
|
|
| C
1
|
| American Autoimmune and Related Disease Association, Asthma and Allergy Foundation of America
|
| Vol #:
|
| 1
|
| |
|
|
| C
2
|
| Connecticut Health Advocacy Forum
|
| Vol #:
|
| 1
|
| |
|
|
| EC
34
|
| Dr. Stephanie Carter
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 1
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 2
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
3
|
| Guidant Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| EMC 4
|
| Number not used
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
5
|
| Academy of Managed Care Pharmacy
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
6
|
| American Association for Geriatric Psychiatry
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
7
|
| BlueCross BlueShield Association
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
8
|
| PhRMA, Pharmaceutical Research and Manufacturers of America
|
| Vol #:
|
| 1
|
| |
|
|
| EMC
9
Attachment
|
| American Heart Association
|
| Vol #:
|
| 1
|
|
|
