|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dockets Entered
On August 10, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic,
Antipyretic & Antirheumatic Products
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function
Claim Notification Letters Dietary
|
|
|
|
|
| 1997S-0163
|
| Dietary Supplements,
Courtesy Letters (Letters of Objection)
|
|
|
|
|
| 1998N-0359
|
| Program priorities/Center
for Food Safety & Applied Nutrition
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed
Cattle Into The Food Supply
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value
for "added sugars"
|
|
|
|
|
| 1999P-5106
|
| Identify Sources of
Natural Flavorings
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry:
Opportunity for Hearing
|
|
|
|
|
| 2001E-0032
|
| Patent Extension for
VISUDYNE, No. 5,095,030
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency
Contraceptives from Rx to OTC
|
|
|
|
|
| 2002N-0500
|
| Classification of Silicone
Sheeting
|
|
|
|
|
| 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
|
|
|
|
|
| 2004D-0193
|
| Guidance for Industry:
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular
and Tissue-Based Products (HCT/Ps)
|
|
|
|
|
| 2004M-0350
|
| Premarket Approval for
Sculptra - P030050
|
|
|
|
|
| 2004M-0356
|
| P030026 - Vitros Immunodiagnostic
Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products
Anti-HBc IgM Calibrator
|
|
|
|
|
| 2004N-0133
|
| Part 11, Electronic
Record; Electronic Signatures; Public Meeting
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to
Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| 2004N-0330
|
| Suicidality in Clinical Trials
for Antidepressant Drugs in Pediatric Patients
|
|
|
| 2004N-0332
|
| Agency Information Collection
Activities: Proposed Collection; Comment Request; Medical Devices; Third
Party Review under FDAMA
|
|
|
|
|
| 2004N-0337
|
| Subpart D IRB Referral, Effects
of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity
Disorder; A Functional Magnetic Resonance Study.
|
|
|
| 2004P-0059
|
| Health Claim Petition:
Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
|
|
|
|
| 2004P-0360
|
| ANDA drug Ferrlecit
Injection 5 ml/62.5 mg of elemental iron
|
|
|
|
|
| 2004S-0233
|
| Stimulating Innovation
in Medical Technologies
|
|
|
|
|
| 1977N-0094
|
| OTC Internal Analgesic,
Antipyretic & Antirheumatic Products
|
|
|
|
|
| ANS
10
|
| HFD-560 to Karl Mallard
|
| Vol #:
|
| 31
|
|
|
|
|
| ANS
11
|
| Edward J. Hiross PhD
|
| Vol #:
|
| 31
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure
Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
14227
|
| Enzymatic Therapy
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14228
|
| Enzymatic Therapy
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14229
|
| Perrigo Company of South
Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14230
|
| Perrigo Company of South
Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14231
|
| Perrigo Company of South
Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14232
|
| Perrigo Company of South
Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14233
|
| Perrigo Company of South
Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14234
|
| Perrigo Company of South
Carolina
|
| Vol #:
|
| 123
|
|
| | | | | | | | |
| |
|
|
| LET
14235
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14236
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14237
|
| Enzymatic Therapy
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14238
|
| MT Sales (U.S.), Inc.
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14239
|
| Crunk LLC
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14240
|
| Botanic Gardens, Inc.
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14241
|
| Botanic Gardens, Inc.
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14242
|
| Botanic Gardens, Inc.
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14243
|
| Botanic Gardens, Inc.
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14244
|
| Botanic Gardens, Inc.
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14245
|
| Enzymatic Therapy
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14246
|
| Enzymatic Therapy
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14247
|
| Enzymatic Therapy
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14248
|
| Bios Biochemicals
|
| Vol #:
|
| 123
|
| |
|
|
| LET
14249
|
| Enzymatic Therapy
|
| Vol #:
|
| 124
|
| |
|
|
| LET
14250
|
| Enzymatic Therapy
|
| Vol #:
|
| 124
|
| |
|
|
| LET
14251
|
| Enzymatic Therapy
|
| Vol #:
|
| 124
|
| |
|
|
| LET
14252
|
| Arbonne International
|
| Vol #:
|
| 124
|
| |
|
|
| LET
14253
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 124
|
| |
|
|
| LET
14254
|
| AdvoCare International, L.P.
|
| Vol #:
|
| 124
|
| |
|
|
| LET
14255
|
| Leiner Health Products
|
| Vol #:
|
| 124
|
| |
|
|
| LET
14256
|
| Leiner Health Products
|
| Vol #:
|
| 124
|
| |
|
|
| LET
14257
|
| Leiner Health Products
|
| Vol #:
|
| 124
|
| |
|
|
| 1997S-0163
|
| Dietary Supplements, Courtesy Letters (Letters of Objection)
|
| |
|
|
| LET
764
|
| HFS-800 to CCA Industries, Inc
|
| Vol #:
|
| 23
|
| |
|
|
| LET
765
|
| HFS-800 to Physician Health Station LLC dba Physician Health Network
|
| Vol #:
|
| 23
|
| |
|
|
| LET
766
|
| HFS-800 to Nutritional Specialties, Inc
|
| Vol #:
|
| 23
|
| |
|
|
| LET
767
|
| HFS-800 to Natural Factors Nutritional Products, Inc
|
| Vol #:
|
| 23
|
| |
|
|
| LET
768
|
| HFS-800 to Natural Factors Nutritional Products, Inc
|
| Vol #:
|
| 23
|
| |
|
|
| LET
769
|
| HFS-800 to Spirit Science USA Inc
|
| Vol #:
|
| 23
|
| |
|
|
| 1998N-0359
|
| Program priorities/Center
for Food Safety & Applied Nutrition
|
| |
|
|
| EC 143
|
| Mrs. Karen Spettel
|
| Vol #:
|
| 9
|
| |
|
|
| EC 144
|
| Ms. Judith McGeary
|
| Vol #:
|
| 9
|
| |
|
|
| EC 145
|
| Mrs. Jane Jenkins
|
| Vol #:
|
| 9
|
| |
|
|
| EC 146
|
| asheville yoga center
|
| Vol #:
|
| 9
|
|
| | | | | | | |
| |
|
|
| EC 147
|
| Ms. Sheril Rathke
|
| Vol #:
|
| 9
|
| |
|
|
| EC 148
|
| Ms. Heather Jones
|
| Vol #:
|
| 9
|
| |
|
|
| EC 149
|
| Ms. Sherree Ros
|
| Vol #:
|
| 9
|
| |
|
|
| EC 150
|
| Ms. Kathleen Vallejo
|
| Vol #:
|
| 9
|
| |
|
|
| EC 151
|
| Radiant Vitality
|
| Vol #:
|
| 9
|
| |
|
|
| EC 152
|
| Mrs. Amy Roberts
|
| Vol #:
|
| 9
|
| |
|
|
| EC 153
|
| susan e mead, m.h, inc.
|
| Vol #:
|
| 9
|
| |
|
|
| EC 154
|
| Mr. Michael Austin
|
| Vol #:
|
| 9
|
| |
|
|
| EC 155
|
| Ms. Nancy Smith
|
| Vol #:
|
| 9
|
| |
|
|
| EC 156
|
| Ms. Mary Ellen Dudley
|
| Vol #:
|
| 9
|
| |
|
|
| EC 157
|
| Mr. David Ehrensperger
|
| Vol #:
|
| 9
|
| |
|
|
| EC 158
|
| Acupuncture and Zero Balancing
|
| Vol #:
|
| 9
|
| |
|
|
| EC 159
|
| Weston Price Foundation
|
| Vol #:
|
| 9
|
| |
|
|
| EC 160
|
| Ms. Elizabeth Thompson
|
| Vol #:
|
| 9
|
| |
|
|
| EC 161
|
| Mrs. Lillian Williams
|
| Vol #:
|
| 9
|
| |
|
|
| EC 162
|
| Sierra Club
|
| Vol #:
|
| 9
|
| |
|
|
| EC 163
|
| Mr. David Kaufman
|
| Vol #:
|
| 9
|
| |
|
|
| EC 164
|
| Mr. james moyer
|
| Vol #:
|
| 9
|
| |
|
|
| EC 165
|
| Mr. Vernon Batty
|
| Vol #:
|
| 9
|
| |
|
|
| EC 166
|
| Natural Marketplace
|
| Vol #:
|
| 9
|
| |
|
|
| EC 167
|
| Los Angeles County Nutrition Task Force
|
| Vol #:
|
| 9
|
| |
|
|
| EC 168
|
| Ms. Claudia Keel
|
| Vol #:
|
| 9
|
| |
|
|
| EC 169
|
| Mr. Charlie Brenner
|
| Vol #:
|
| 9
|
| |
|
|
| EC 170
|
| Mr. Jason Sullivan
|
| Vol #:
|
| 9
|
| |
|
|
| EC 171
|
| NONE
|
| Vol #:
|
| 9
|
| |
|
|
| EC 172
|
| robert manchester
|
| Vol #:
|
| 9
|
| |
|
|
| EC 173
|
| Mr. Vince Cukrov
|
| Vol #:
|
| 9
|
| |
|
|
| EC 174
|
| Ms. Sharon Donegan
|
| Vol #:
|
| 9
|
| |
|
|
| EC 175
|
| Ms. Danielle White
|
| Vol #:
|
| 9
|
| |
|
|
| EC 176
|
| Mr. Mark Edwards
|
| Vol #:
|
| 9
|
| |
|
|
| EC 177
|
| Ms. Sarah Segal
|
| Vol #:
|
| 9
|
| |
|
|
| EC 178
|
| Mr. Nelson Skinner
|
| Vol #:
|
| 9
|
| |
|
|
| EC 179
|
| Ms. Lyn Gottschalk
|
| Vol #:
|
| 9
|
| |
|
|
| EC 180
|
| Ms. Janice Smith
|
| Vol #:
|
| 9
|
| |
|
|
| EC 181
|
| Ms. Mare Wahosi
|
| Vol #:
|
| 9
|
| |
|
|
| EC 182
|
| Mrs. Sandra Cutter
|
| Vol #:
|
| 9
|
| |
|
|
| EC 183
|
| Dr. Karen Larson
|
| Vol #:
|
| 9
|
|
| | | | | | | |
| |
|
|
| EC 184
|
| Mrs. Andrea Shrote
|
| Vol #:
|
| 9
|
| |
|
|
| EC 185
|
| Mr. Anthony Moutis
|
| Vol #:
|
| 9
|
| |
|
|
| EC 186
|
| Dr. Karen Boone
|
| Vol #:
|
| 9
|
| |
|
|
| EC 187
|
| Ms. Dee Halzack
|
| Vol #:
|
| 9
|
| |
|
|
| EC 188
|
| consumer of shrimp
|
| Vol #:
|
| 9
|
| |
|
|
| EC 189
|
| Ms. Sandra Duggan
|
| Vol #:
|
| 9
|
| |
|
|
| EC 190
|
| Ms. Jo Wilhelm
|
| Vol #:
|
| 9
|
| |
|
|
| EC 191
|
| Ms. Shir Lee Cox
|
| Vol #:
|
| 9
|
| |
|
|
| EC 192
|
| Mrs. Jo Tellone
|
| Vol #:
|
| 9
|
| |
|
|
| EC 193
|
| Mr. David Williams
|
| Vol #:
|
| 9
|
| |
|
|
| EC 194
|
| Ms. Bridget Chisholm
|
| Vol #:
|
| 9
|
| |
|
|
| EC 195
|
| Mr. David Houck
|
| Vol #:
|
| 9
|
| |
|
|
| EC 196
|
| Ms. Emily Bloss
|
| Vol #:
|
| 9
|
| |
|
|
| EC 197
|
| Weston A. Price Foundation - Lansing
|
| Vol #:
|
| 9
|
| |
|
|
| EC 198
|
| Ms. Diana Winer
|
| Vol #:
|
| 9
|
| |
|
|
| EC 199
|
| Mrs. Margaret Shockley Gandy
|
| Vol #:
|
| 9
|
| |
|
|
| EC 200
|
| Mr. Philip Combs
|
| Vol #:
|
| 9
|
| |
|
|
| EC 201
|
| Mr. walter garvin
|
| Vol #:
|
| 9
|
| |
|
|
| EC 202
|
| Mr. Erik Lords
|
| Vol #:
|
| 9
|
| |
|
|
| EC 203
|
| Mr. steven lucas
|
| Vol #:
|
| 9
|
| |
|
|
| EC 204
|
| Miss. Mindy McKinley
|
| Vol #:
|
| 9
|
| |
|
|
| EC 205
|
| Mrs. Evalyn F. Segal
|
| Vol #:
|
| 9
|
| |
|
|
| EC 206
|
| Mr. Lamont Sweisberger
|
| Vol #:
|
| 9
|
| |
|
|
| EC 207
|
| Ms. Barbara Henderson
|
| Vol #:
|
| 9
|
| |
|
|
| EC 208
|
| Mrs. Laurie Fisher
|
| Vol #:
|
| 9
|
| |
|
|
| EC 209
|
| Mr. Chris Jordan
|
| Vol #:
|
| 9
|
| |
|
|
| EC 210
|
| Ms. Danielle Kerr
|
| Vol #:
|
| 9
|
| |
|
|
| EC 211
|
| Ms. Rachael Denny
|
| Vol #:
|
| 9
|
| |
|
|
| EC 212
|
| Mrs. Mary Hruby
|
| Vol #:
|
| 9
|
| |
|
|
| EC 213
|
| Global Policy Network
|
| Vol #:
|
| 9
|
| |
|
|
| EC 214
|
| Ms. Frances Renaud
|
| Vol #:
|
| 9
|
| |
|
|
| EC 215
|
| Ms. CYNTHIA ELLIOTT
|
| Vol #:
|
| 9
|
| |
|
|
| EC 216
|
| Mrs. Karen Barney
|
| Vol #:
|
| 9
|
| |
|
|
| EC 217
|
| Mr. James Salter
|
| Vol #:
|
| 9
|
| |
|
|
| EC 218
|
| Mr. jimmy McGraw
|
| Vol #:
|
| 9
|
| |
|
|
| EC 219
|
| Dr. robert morgan
|
| Vol #:
|
| 9
|
| |
|
|
| EC 220
|
| Ms. June Krell
|
| Vol #:
|
| 9
|
|
| | | | | | | | |
| |
|
|
| EMC
17
|
| American Society for Microbiology (ASM)
|
| Vol #:
|
| 8
|
| |
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
| |
|
|
| EMC 4247
|
| H. Wagner
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4248
|
| No signature
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4249
|
| No signature
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4250
|
| S. Norris
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4251
|
| R. Austin
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4252
|
| No signature
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4253
|
| L. Baldwin
|
| Vol #:
|
| 304
|
| |
|
|
| EMC 4254
|
| D. Damme, M.A.
|
| Vol #:
|
| 304
|
| |
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
| |
|
|
| EMC 793
|
| Asha
|
| Vol #:
|
| 33
|
| |
|
|
| 1999P-5106
|
| Identify Sources of Natural Flavorings
|
| |
|
|
| EMC 199
|
| L. Partyka
|
| Vol #:
|
| 2
|
| |
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
| |
|
|
| C
269
|
| Alpharma Inc.
|
| Vol #:
|
| 99
|
| |
|
|
| C
270
|
| Jennie-O Turkey Store
|
| Vol #:
|
| 99
|
| |
|
|
| 2001E-0032
|
| Patent Extension for VISUDYNE, No. 5,095,030
|
| |
|
|
| APP
2
Part 2, 3,
4
|
| University of British Columbia
|
| Vol #:
|
| 2
|
| |
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
| |
|
|
| EMC 10222
|
| M. Thomaston
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10223
|
| L. Shopp
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10224
|
| J. Howell
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10225
|
| A. Thompson
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10226
|
| E. Glenn
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10227
|
| P. Fisk
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10228
|
| S. Perry
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10229
|
| S. Read
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10230
|
| J. Katz
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10231
|
| J. Brumm
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10232
|
| K. Kubale
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10233
|
| A. Haggerty
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10234
|
| M. Smith, M.A.
|
| Vol #:
|
| 287
|
|
| | | | | | | | |
| |
|
|
| EMC 10235
|
| J. Booze
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10236
|
| M. Noble
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10237
|
| No signature
|
| Vol #:
|
| 287
|
| |
|
|
| EMC 10238
|
| S. Robertson
|
| Vol #:
|
| 287
|
| |
|
|
| 2002N-0500
|
| Classification of Silicone Sheeting
|
| |
|
|
| NFR
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
| |
|
|
| EMC
358
|
| Mission Possible International
|
| Vol #:
|
| 6
|
| |
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
| |
|
|
| EMC 327
|
| No signature
|
| Vol #:
|
| 8
|
| |
|
|
| EMC 328
|
| J. Filegar
|
| Vol #:
|
| 8
|
| |
|
|
| 2004D-0193
|
| Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
|
| |
|
|
| EMC 1
|
| Form Letters
|
| Vol #:
|
| 4
|
| |
|
|
| EMC 2
|
| J. Farber
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 3
|
| S. Betzalel
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 4
|
| M. Harding
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 5
|
| J. Maxwell
|
| Vol #:
|
| 2
|
| |
|
|
| EMC 6
|
| A. Dosedal
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 7
|
| B. Wood
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 8
|
| C. Kyrish
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 9
|
| C. Brown
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 10
|
| A. Erguven
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 11
|
| D. Wimmer
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 12
|
| A. Hill
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 13
|
| A. Gowtam
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 14
|
| G. Howard
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 15
|
| E. Hughes
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 16
|
| Dr. D. Fouts
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 17
|
| C. Guerra,MD,FACP
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 18
|
| B. Montgomery
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 19
|
| S and A Brown
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 20
|
| J. Richmond
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 21
|
| C. Azrin
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 22
|
| E. Byunn
|
| Vol #:
|
| 5
|
|
| | | | | | | |
|
|
|
| EMC 23
|
| J. Cunningham
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 24
|
| C. Dardis
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 25
|
| E. Ramsey
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 26
|
| K. Heppe
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 27
|
| E. Lopez
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 28
|
| R. Johnston
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 29
|
| M. Young
|
| Vol #:
|
| 5
|
| |
|
|
| EMC
30
|
| Dunn & Sheldrick, P.S.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 31
|
| K. Davies
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 32
|
| K. Harkins
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 33
|
| A. Fenelon
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 34
|
| J. Hague
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 35
|
| R. Kaerskov
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 36
|
| K. Meinig
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 37
|
| M. Fogleman
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 38
|
| S. Feng, M.D.
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 39
|
| L. Hart
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 40
|
| M. Earle
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 41
|
| S. Schwartz
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 42
|
| S and D Telling
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 43
|
| J. Adams
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 44
|
| K. Rogers
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 45
|
| M. Gail, CAE
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 46
|
| M. Oh
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 47
|
| R. Lex
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 48
|
| S. Linton
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 49
|
| S. Amoroso
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 50
|
| J. Brown
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 51
|
| K. Myrdahl
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 52
|
| F. Galimi
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 53
|
| M. Kutscher,CFA,CFP
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 54
|
| K. Enright
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 55
|
| E and G Fleming
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 56
|
| C. Stephen
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 57
|
| C. Kornmehl, MD,FACRO
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 58
|
| J. Strong
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 59
|
| V. Remolador
|
| Vol #:
|
| 5
|
|
| | | | | | | |
| |
|
|
| EMC 60
|
| K. Foust
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 61
|
| H. Le, MD
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 62
|
| L. Moreno
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 63
|
| D. Pfund
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 64
|
| C and M Biggs
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 65
|
| T. Hurd
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 66
|
| E. Thomas
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 67
|
| S. Barnes
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 68
|
| J. Hohnen
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 69
|
| A and B Taylor
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 70
|
| L. Saenz
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 71
|
| K. Doyle
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 72
|
| S. Perry
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 73
|
| R. Yemm
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 74
|
| P. Armstrong
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 75
|
| C. Briggeman
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 76
|
| M. Hershock
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 77
|
| Dr. J. Black
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 78
|
| L. Burbach
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 79
|
| K. Kovac
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 80
|
| D. Holtz
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 81
|
| N. Hermann
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 82
|
| C. and M Brown
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 83
|
| M. Elliott
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 84
|
| T Pellegrino
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 85
|
| R. Azrin
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 86
|
| L. Carter
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 87
|
| J. Heinemann
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 88
|
| C. Soviero
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 89
|
| D. Babbush
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 90
|
| K. Linza
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 91
|
| M. Peeks
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 92
|
| M. Sharma
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 93
|
| K and E Stack
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 94
|
| D. Ciardullo
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 95
|
| P and K Titcombe
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 96
|
| S. Klepper
|
| Vol #:
|
| 5
|
|
| | | | | | | |
| |
|
|
| EMC 97
|
| D. Jennings
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 98
|
| D. Earle
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 99
|
| J. Gingeleskie
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 100
|
| L. Hayes
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 101
|
| R. Ollerenshaw
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 102
|
| N. Matnick
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 103
|
| D. Gavin
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 104
|
| K. Downie
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 105
|
| S. Scarcello
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 106
|
| S. Kregear
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 107
|
| P. Buck, PhD
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 108
|
| R. O'Neil
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 109
|
| E. Ball
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 110
|
| T. Purchase
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 111
|
| S. Saini, MD
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 112
|
| P. Jackson
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 113
|
| J. Knott
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 114
|
| E. Villarreal
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 115
|
| D. Esslinger
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 116
|
| A. Murdock
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 117
|
| L. Lee
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 118
|
| Mr and Mrs D Ciotta
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 119
|
| W. Bryant
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 120
|
| B and E Greenspan
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 121
|
| J. Brown
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 122
|
| S. Scott
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 123
|
| M. Wiegand
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 124
|
| N. Thomas
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 125
|
| K. Mullarkey
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 126
|
| T and K Feldman
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 127
|
| J. Shafer
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 128
|
| K. Rodman
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 129
|
| K. Hubbard
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 130
|
| Dr. C. Inge
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 131
|
| L. Emouna
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 132
|
| M. Voe
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 133
|
| S. Leverette
|
| Vol #:
|
| 5
|
|
| | | | | | | | |
| |
|
|
| EMC 134
|
| D. Sanchez
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 135
|
| L. Pojano
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 136
|
| J. Rickers and Z. Blatter
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 137
|
| M. Aparicio
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 138
|
| L. Khan
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 139
|
| C. Ivey
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 140
|
| K. Marks
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 141
|
| B. Chisholm
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 142
|
| M. Cherrin
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 143
|
| M. Belzer
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 144
|
| R. Baldwin
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 145
|
| L. Moss
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 146
|
| A. Lamberson
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 147
|
| K. Woodbury
|
| Vol #:
|
| 5
|
| |
|
|
| EMC 148
|
| G. Bell
|
| Vol #:
|
| 5
|
| |
|
|
| 2004M-0350
|
| Premarket Approval for Sculptra - P030050
|
| |
|
|
| AAV
1
|
| Dermik Laboratories
|
| Vol #:
|
| 1
|
| |
|
|
| 2004M-0356
|
| P030026 - Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator
|
| |
|
|
| AAV
1
|
| Ortho-Clinical Diagnostics, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
| |
|
|
| EMC
75
Attachment
|
| International Assn for Pharmaceutical Technology (APV)
|
| Vol #:
|
| 6
|
| |
|
|
| 2004N-0181
|
| Critical Path Initiative
|
| |
|
|
| EMC
16
|
| National Coalition for Cancer Survivorship (NCCS)
|
| Vol #:
|
| 3
|
| |
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
| |
|
|
| EC 2
|
| Miss. Rhonda Pumphrey
|
| Vol #:
|
| 7
|
| |
|
|
| EC 3
|
| McDonald's Corporation
|
| Vol #:
|
| 7
|
| |
|
|
| EC 4
|
| Dr. Terri White
|
| Vol #:
|
| 7
|
| |
|
|
| EMC 150
|
| J. Sparks
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 151
|
| D. Havard
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 152
|
| H. Leef
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 153
|
| M. Mears
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 154
|
| C. Coulombe
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 155
|
| T. Robertson
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 156
|
| P. O'Connell
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
| |
|
|
| EMC
157
|
| American Meat Institute et al
|
| Vol #:
|
| 6
|
| |
|
|
| EMC
158
|
| Waitaki Biosciences International Ltd.
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 159
|
| I. Hastings
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 160
|
| K. Harrison
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 161
|
| M. Tilschner
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 162
|
| K. Clark
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 163
|
| C. Koroll
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 164
|
| T. Rodman
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 165
|
| S. Emberson
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 166
|
| K. Moffitt
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 167
|
| T. Taylor
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 168
|
| Z. Gilbreath
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 169
|
| K. Freeza
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 170
|
| B. Anderson
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 171
|
| E. Scheid
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 172
|
| L. Lewallen
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 173
|
| E. Glenn
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 174
|
| B. Chapones
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 175
|
| M. Jerred
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 176
|
| J. Eggleston
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 177
|
| T. Hall
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 178
|
| P. Maly
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 179
|
| M. Dombek
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 180
|
| A. Cimino
|
| Vol #:
|
| 6
|
| |
|
|
| EMC 181
|
| C. Nelson
|
| Vol #:
|
| 6
|
| |
|
|
| 2004N-0330
|
| Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients
|
| |
|
|
| EC 1
|
| Mrs. Sandi Payne
|
| Vol #:
|
| 1
|
| |
|
|
| EC 2
|
| Cryonic Life Insurance Company
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0332
|
| Agency Information Collection Activities: Proposed Collection; Comment Request; Medical Devices; Third Party Review under FDAMA
|
| |
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2004N-0337
|
| Subpart D IRB Referral, Effects of a Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; A Functional Magnetic Resonance Study.
|
| |
|
|
| EC 1
|
| Kaiser Permanente
|
| Vol #:
|
| 1
|
| |
|
|
| 2004P-0059
|
| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
| |
|
|
| ANS
2
|
| HFS-800 to Emord & Associates
|
| Vol #:
|
| 13
|
|
| | | | | | | | |
| |
|
|
| LET
6
|
| Weider Nutrition International, Inc.
|
| Vol #:
|
| 13
|
| |
|
|
| LET
7
|
| Weider Nutrition International, Inc.
|
| Vol #:
|
| 13
|
| |
|
|
| 2004P-0360
|
| ANDA drug Ferrlecit Injection 5 ml/62.5 mg of elemental iron
|
| |
|
|
| ACK
1
|
| AAC Consulting Group
|
| Vol #:
|
| 1
|
| |
|
|
| CP
1
Attachment
A, B
|
| AAC Consulting Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2004S-0233
|
| Stimulating Innovation in Medical Technologies
|
| |
|
|
| C
3
|
| National Venture Capital Association
|
| Vol #:
|
| 1
|
|
|
