|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dockets Entered
On August 5, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket
#
|
| Title
|
|
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function
Claim Notification Letters Dietary
|
|
|
|
|
| 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
|
|
|
|
|
| 2001P-0345
|
| Listing the color
additive yellow #5 for use in food/Drug
|
|
|
|
|
| 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
|
|
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request
for Information
|
|
|
|
|
| 2003N-0338
|
| Obesity
|
|
|
|
|
| 2003P-0029
|
| Remove metered-dose
inhalers (MDI) containing moiety albuter
|
|
|
|
|
| 2003P-0574
|
| Regulatory limit for
Listeria monocytogenes in ready-to-eat foods that do not support its
growth
|
|
|
|
|
| 2004M-0341
|
| P030024 - Vitros Immunodiagnostic
Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products
Anti-HBc Calibrator
|
|
|
|
|
| 2004M-0342
|
| P040008 - VIDAS TPSA
assay
|
|
|
|
|
| 2004M-0345
|
| Premarket Approval
for CureLight BroadBand by PhotoCure ASA (Model CureLight 01) P010061
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to
Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| 2004P-0351
|
| Change the labeling
and take futher action to address the association of Viagra(Sildenafil)
use and increased STD transmission, includig HIV infection
|
|
|
|
|
| 2004P-0353
|
| ANDA Suitability for
Famotidine Orally Dissolving Strips 10 mg
|
|
|
|
|
| 2004P-0354
|
| CEDIA Sirolimus Assay
as a class II device
|
|
|
|
|
| 2004S-0270
|
| Notice Announcing
Publication of the Report to Congress Entitled Plan for the Transfer
of Responsibility for Medicare Appeals and Soliciting Comments
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure
Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
14161
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14162
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14163
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14164
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14165
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14166
|
| Solgar Vitamin and
Herbs
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14167
|
| Solgar Vitamin and
Herb
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14168
|
| Perrigo Company of
South Carolina
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14169
|
| Inverness Medical
Nutritionals Group
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14170
|
| Your Vitamins
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14171
|
| Source Naturals
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14172
|
| Source Naturals
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14173
|
| Source Naturals
|
| Vol #:
|
| 123
|
|
| | | | | | | | |
|
|
|
|
| LET
14174
|
| The Monticello Drug Company
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14175
|
| EM Hawaii Incorporated
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14176
|
| IntegrativeTherapeutics Inc.
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14177
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14178
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14179
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14180
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14181
|
| Integrative Therapeutics Inc.
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14182
|
| Enzymatic Therapy
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14183
|
| Your Vitamins
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14184
|
| Natreon, Inc.
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14185
|
| Atkins Nutritionals, Inc.
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14186
|
| Sierra Mountain Minerals, Inc.
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14187
|
| Enzmyatic Therapy
|
| Vol #:
|
| 123
|
|
|
|
|
| LET
14188
|
| Pharmavite LLC
|
| Vol #:
|
| 123
|
|
|
|
|
| 1998N-0359
|
| Program priorities/Center
for Food Safety & Applied Nutrition
|
|
|
|
|
| EC 132
|
| Mrs. Sonja Kepford
|
| Vol #:
|
| 9
|
|
|
|
|
| EC 133
|
| Ms. Enid Futterman
|
| Vol #:
|
| 9
|
|
|
|
|
| EC 134
|
| Mrs. Donna Spencer
|
| Vol #:
|
| 9
|
|
|
|
|
| EC 135
|
| Dr. Kem Moser
|
| Vol #:
|
| 9
|
|
|
|
|
| EC 136
|
| Ms. Sharon Conti
|
| Vol #:
|
| 9
|
|
|
|
|
| EC 137
|
| Ms. Eleanor Brosius
|
| Vol #:
|
| 9
|
|
|
|
|
| EC 138
|
| Mrs. Karen McFarland
|
| Vol #:
|
| 9
|
|
|
|
|
| EC 139
|
| Mr. Alex Polemeropoulos
|
| Vol #:
|
| 9
|
|
|
|
|
| EC 140
|
| Dr. Matt Barnes
|
| Vol #:
|
| 9
|
|
|
|
|
| EC 141
|
| Mrs. Cynthia Long
|
| Vol #:
|
| 9
|
|
|
|
|
| EC
142
|
| North American Millers' Association
|
| Vol #:
|
| 9
|
|
| |
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| EMC 4244
|
| A. Pariser
|
| Vol #:
|
| 304
|
|
|
|
|
| EMC 4245
|
| J. Potter
|
| Vol #:
|
| 304
|
|
|
|
|
| EMC 4246
|
| R. Briggs
|
| Vol #:
|
| 304
|
|
|
|
|
| 1999P-2630
|
| Establish a Daily Value for "added sugars"
|
|
|
|
|
| EMC 791
|
| M. Wilson
|
| Vol #:
|
| 33
|
|
|
|
|
| EMC 792
|
| RM Bramlett
|
| Vol #:
|
| 33
|
|
|
|
|
| 1999P-5106
|
|
| | | | | | | | |
|
|
|
|
| Identify Sources of Natural Flavorings
|
|
|
|
|
| EMC 196
|
| P. Brooks
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 197
|
| N. McLachlin
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 198
|
| L. McBride
|
| Vol #:
|
| 2
|
|
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
|
|
| EXB 449
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 427
|
|
|
|
|
| EXB 450
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 427
|
|
|
|
|
| EXB 451
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 428
|
|
|
|
|
| EXB 452
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 428
|
|
|
|
|
| EXB 453
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 428
|
|
|
|
|
| EXB 454
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 428
|
|
|
|
|
| EXB 455
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 428
|
|
|
|
|
| EXB 456
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 428
|
|
|
|
|
| EXB 457
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 428
|
|
|
|
|
| EXB 458
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 428
|
|
|
|
|
| 2001P-0345
|
| Listing the color additive yellow #5 for use in food/Drug
|
|
|
|
|
| EMC 1243
|
| Nelson
|
| Vol #:
|
| 5
|
|
|
|
|
| 2002P-0317
|
| Recall Aspartame as a Neurotoxic Drug
|
|
|
|
|
| EMC
353
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
354
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
355
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
356
Attachment
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
357
|
| Mission Possible International
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
|
|
| EMC 322
|
| J. Stine
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 323
|
| I. Kot
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 324
|
| S. Bullard
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 325
|
| D. Singleton
|
| Vol #:
|
| 8
|
|
|
|
|
| EMC 326
|
| D. Nuttall
|
| Vol #:
|
| 8
|
|
|
|
|
| 2003N-0169
|
| Dental Amalgam; Request for Information
|
|
|
|
|
| EMC
241
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
242
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
243
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
244
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
|
|
|
| EMC
245
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
246
|
| Consumers for Dental Choice
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC 247
|
| M. Rygg
|
| Vol #:
|
| 6
|
|
| |
|
| 2003N-0338
|
| Obesity
|
|
|
|
|
| EMC
58
|
| Pennington Biomedical Research Center
|
| Vol #:
|
| 12
|
|
|
|
|
| 2003P-0029
|
| Remove metered-dose inhalers (MDI) containing moiety albuter
|
|
|
|
|
| EMC
23
|
| American Academy of Allergy, Asthma and Immunology (AAAAI)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC 24
|
| R. Carlson
|
| Vol #:
|
| 2
|
|
|
|
|
| 2003P-0574
|
| Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth
|
|
|
|
|
| EMC
4
|
| American Scociety for Microbiology (ASM)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004M-0341
|
| P030024 - Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator
|
|
|
|
|
| AAV
1
|
| Ortho-Clinical Diagnostics, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004M-0342
|
| P040008 - VIDAS TPSA assay
|
|
|
|
|
| AAV
1
|
| bioMerieux, Inc.
|
| Vol #:
|
| 1
|
|
| |
|
| 2004M-0345
|
| Premarket Approval for CureLight BroadBand by PhotoCure ASA (Model CureLight 01) P010061
|
|
|
|
|
| AAV
1
|
| PhotoCure ASA
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0181
|
| Critical Path Initiative
|
|
|
|
|
| EMC
2
|
| AIDS Vaccine Advocacy Coalition (AVAC)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
3
|
| Plasma Protein Therapeutics Assn (PPTA)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
4
|
| Merck & Co., Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
5
|
| Amgen, Inc.
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
6
|
| Marti Nelson Cancer Foundation
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
7
|
| American Society of Clinical Oncology
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
8
|
| American Academy of Orthopaedic Surgeons (AAOS/Academy)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
9
|
| Millennium Pharmaceuticals, Inc. (Millennium)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
10
|
| Massachusetts Biotechnology Council (MBC)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
11
|
| PBG Consulting
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
12
|
| American Society for Microbiology (ASM)
|
| Vol #:
|
| 2
|
|
|
|
|
| EMC
13
|
| Biotechnology Industry Organization (BIO)
|
| Vol #:
|
| 2
|
|
|
|
|
| 2004N-0264
|
| Federal Measures to Mitigate BSE Risks: Considerations for Further Action
|
|
|
|
|
| EMC
46
Attachment
|
| Cargill, Inc.
|
| Vol #:
|
| 6
|
|
|
|
|
| EMC
47
|
| Cargill Animal Nutrition
|
| Vol #:
|
| 6
|
|
| | | | | | | | |
|
|
|
|
| CP
1
|
| STD Prevention and Control Service
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0353
|
| ANDA Suitability for Famotidine Orally Dissolving Strips 10 mg
|
|
|
|
|
| ACK
1
|
| HFA-305 to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| CP
1
Attachment 1,
2,
3
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004P-0354
|
| CEDIA Sirolimus Assay as a class II device
|
|
|
|
|
| CP
1
Attachment
|
| Microgenics Corporation
|
| Vol #:
|
| 1
|
|
|
|
|
| PAV
1
|
| Steven I. Gutman
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004S-0270
|
| Notice Announcing Publication of the Report to Congress Entitled Plan for the Transfer of Responsibility for Medicare Appeals and Soliciting Comments
|
|
|
|
|
| EMC
7
|
| America's Health Insurance Plans
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 8
|
| Robin J Arzt
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC 9
|
| Robin J Arzt
|
| Vol #:
|
| 1
|
|
|
|
|
| EMC
10
|
| Association of Administrative Law Judges
|
| Vol #:
|
| 1
|
|
