| | | | | | | | | | |
|
| |
|
| Dockets Entered
On March 31, 2004
Table of Contents
|
|
|
|
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
|
|
| 1978N-0036L
|
| OTC Laxative
|
|
|
|
|
| 1988N-0258
|
| Prescription Drug Marketing Act of 1987; Guideline
|
|
|
|
|
| 1992N-0297
|
| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
|
|
|
|
|
| 1993N-0195
|
| Safe Processing & Importing of Fish & Fishery Products
|
|
|
|
|
| 1996F-0176
|
| Safe Use of Nylon 6/12 Copolymers for use as a non-food cont
|
|
|
|
|
| 1997P-0197
|
| Require that warning labels about risks of salmonella enteri
|
|
|
|
|
| 1997P-0329
|
| Require Quantitative Labeling of Caffeine Content
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| 1998P-0504
|
| Raw Molluscan Shellfish of Undetectable Levels
|
|
|
|
|
| 2001N-0067
|
| Reclassification of Dental Mercury
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
|
|
|
|
| 2002P-0139
|
| Arava (leflunomide;Aventis) remove from the market
|
|
|
|
|
| 2003N-0161
|
| Medical Devices;Reprocessed Single-Use Devices;Termination
|
|
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
|
|
| 2003P-0276
|
| Establish Interim Acceptable Levels for Acrylamide In Major Food Sources
|
|
|
|
|
| 2003P-0552
|
| ANADA for a generic new animal drug caroprofen
|
|
|
|
|
| 2004M-0145
|
| P020006 - Enteryx Procedure Kit, Approved 4/22/03
|
|
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
|
|
| 2004V-0155
|
| Valley Forge Composite Technologies Explosive Detection Systems
|
|
| |
|
| 1978N-0036L
|
| OTC Laxative
|
|
|
|
|
| RC
2
|
| C.B. Fleet Company, Inc.
|
| Vol #:
|
| 137
|
|
|
|
|
| 1988N-0258
|
| Prescription Drug Marketing Act of 1987; Guideline
|
|
|
|
|
| PAV
1
|
| HFC-1 to Kleinfeld Kaplan & Becker, LLP
|
| Vol #:
|
| 6
|
|
|
|
|
| 1992N-0297
|
| Prescription Drug Marketing Act of 1987, Drug Amds of 1992
|
|
|
|
|
| PAV
1
|
| HFC-1 to Kleinfeld, Kaplan & Becker, LLP
|
| Vol #:
|
| 8
|
|
|
|
|
| 1993N-0195
|
| Safe Processing & Importing of Fish & Fishery Products
|
|
|
|
|
| C 301
|
| E. Evans
|
| Vol #:
|
| 25
|
|
|
|
|
| 1996F-0176
|
| Safe Use of Nylon 6/12 Copolymers for use as a non-food cont
|
|
|
|
|
| NCR
1
|
| FDA
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
|
| 1997P-0197
|
| Require that warning labels about risks of salmonella enteri
|
|
|
|
|
| C 847
|
| L. Alvord
|
| Vol #:
|
| 32
|
|
|
|
|
| C 848
|
| A. Suniga
|
| Vol #:
|
| 32
|
|
|
|
|
| C 849
|
| M. Rubenstein
|
| Vol #:
|
| 32
|
|
|
|
|
| C 850
|
| M. Elder
|
| Vol #:
|
| 32
|
|
|
|
|
| C 851
|
| E. Daniels
|
| Vol #:
|
| 32
|
|
|
|
|
| 1997P-0329
|
| Require Quantitative Labeling of Caffeine Content
|
|
|
|
|
| C 260
|
| R. Whalen,MLT
|
| Vol #:
|
| 8
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
|
|
| LET
13457
|
| The House of Yin Yang (BVI) Ltd.
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13458
|
| The House Of Yin Yang (BVI) Ltd.
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13459
|
| The House of Yin Yang (BVI) Ltd.
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13460
|
| The House Of Yin Yang (BVI) Ltd.
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13461
|
| The House of Yin Yang (BVI) Ltd.
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13462
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13463
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13464
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13465
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13466
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13467
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13468
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13469
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13470
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13471
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13472
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13473
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13474
|
| Optimum Nutrition, Inc.
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13475
|
| Optimum Nutrition, Inc.
|
| Vol #:
|
| 111
|
|
|
|
|
| LET
13476
|
| Optimum Nutrition, Inc.
|
| Vol #:
|
| 111
|
|
|
|
|
| 1998P-0151
|
| Introduction Of Downed Cattle Into The Food Supply
|
|
|
|
|
| C 7393
|
| C. Kanyo
|
| Vol #:
|
| 307
|
|
|
|
|
| C 7394
|
| M. Cummings
|
| Vol #:
|
| 307
|
|
|
|
|
| C 7395
|
| D and L Halper
|
| Vol #:
|
| 307
|
|
|
|
|
| C 7396
|
| B. Powers
|
| Vol #:
|
| 207
|
|
|
|
|
| C 7397
|
| Y. Eyre
|
| Vol #:
|
| 307
|
|
| | | | | | | | |
|
|
|
|
| C 7398
|
| Drs K and K Waldman
|
| Vol #:
|
| 307
|
|
|
|
|
| C 7399
|
| A. Powers
|
| Vol #:
|
| 307
|
|
| |
|
| 1998P-0504
|
| Raw Molluscan Shellfish of Undetectable Levels
|
|
|
|
|
| C 287
|
| L. Alvord
|
| Vol #:
|
| 31
|
|
|
|
|
| C 288
|
| A. Suniga
|
| Vol #:
|
| 31
|
|
|
|
|
| C 289
|
| M. Elder
|
| Vol #:
|
| 31
|
|
|
|
|
| C 290
|
| M. Rubenstein
|
| Vol #:
|
| 31
|
|
|
|
|
| C 291
|
| E. Daniels
|
| Vol #:
|
| 31
|
|
|
|
|
| 2001N-0067
|
| Reclassification of Dental Mercury
|
|
|
|
|
| SUP
5
|
| Consumers for Dental Choice
|
| Vol #:
|
| 18
|
|
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
|
|
| C 1333
|
| D. Bilhorn,MD,FACOG
|
| Vol #:
|
| 209
|
|
|
|
|
| C 1334
|
| No signature
|
| Vol #:
|
| 209
|
|
|
|
|
| C 1335
|
| P. Sluis
|
| Vol #:
|
| 209
|
|
|
|
|
| C 1336
|
| E. Hand, Pharm.D.
|
| Vol #:
|
| 209
|
|
|
|
|
| C 1337
|
| R. Hanna,MD
|
| Vol #:
|
| 209
|
|
|
|
|
| C
1338
|
| Advanced Women's Care
|
| Vol #:
|
| 209
|
|
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness; Registration of Food Facilities
|
|
|
|
|
| C
218
|
| United Parcel Service, Inc. (UPS)
|
| Vol #:
|
| 20
|
|
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
|
|
| C
293
|
| Federal Express Corporation (FedEx)
|
| Vol #:
|
| 22
|
|
|
|
|
| 2002N-0534
|
| Medical Device User Fee and Modernization Act of 2002
|
|
|
| C
38
|
| Advanced Medical Technology Assn (AdvaMed
|
| Vol #:
|
| 2
|
|
|
|
|
| 2002P-0139
|
| Arava (leflunomide;Aventis) remove from the market
|
|
|
|
|
| PDN
1
|
| HFD-1 to Public Citizen Health Research Group
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003N-0161
|
| Medical Devices;Reprocessed Single-Use Devices;Termination
|
|
|
|
|
| C
3
|
| Advanced Medical Technology Assn (AdvaMed
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0270
|
| Prohibit False and Misleading Labeling
|
|
|
|
|
| C 64
|
| R. Anderson
|
| Vol #:
|
| 6
|
|
|
|
|
| C 65
|
| C. Chase
|
| Vol #:
|
| 6
|
|
|
|
|
| 2003P-0276
|
| Establish Interim Acceptable Levels for Acrylamide In Major Food Sources
|
|
| | | | | | | | |
|
|
|
|
| C 20
|
| L. Alvord
|
| Vol #:
|
| 1
|
|
|
|
|
| C 21
|
| A. Suniga
|
| Vol #:
|
| 1
|
|
|
|
|
| C 22
|
| M. Elder
|
| Vol #:
|
| 1
|
|
|
|
|
| C 23
|
| M. Rubenstein
|
| Vol #:
|
| 1
|
|
|
|
|
| C 24
|
| E. Daniels
|
| Vol #:
|
| 1
|
|
|
|
|
| 2003P-0552
|
| ANADA for a generic new animal drug caroprofen
|
|
|
|
|
| PAV
1
|
| HFV-100 to Jurox PTY, Limited
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004M-0145
|
| P020006 - Enteryx Procedure Kit, Approved 4/22/03
|
|
|
|
|
| AAV
1
|
| Enteric Medical Technologies, Inc.
|
| Vol #:
|
| 1
|
|
|
|
|
| 2004N-0115
|
| Prescription Drug Importation Study
|
|
|
|
|
| C
1
|
| National Alliance for the Mentally Ill (NAMI)
|
| Vol #:
|
| 1
|
|
|
|
|
| LST
1
|
| List of Attendees for March 19, 2004 Meeting
|
| Vol #:
|
| 1
|
|
|
|
|
| LST
2
|
| Agenda for Consumer Stakeholder Meeting 03/19/2004
|
| Vol #:
|
| 1
|
|
|
|
|
| REF
1
|
| Press Release - HHS News
|
| Vol #:
|
| 1
|
|
|
|
|
| TS
1
|
| Minnesota Senior Federation-Metropolitan Region
|
| Vol #:
|
| 1
|
|
|
|
|
| TS
2
|
| Families USA
|
| Vol #:
|
| 1
|
|
|
|
|
| TS
3
|
| Older Women's League
|
| Vol #:
|
| 1
|
|
|
|
|
| TS
4
|
| Medicare Rights Center
|
| Vol #:
|
| 1
|
|
|
|
|
| TS
5
|
| AARP
|
| Vol #:
|
| 1
|
|
|
|
|
| TS
6
|
| Consumer Alert
|
| Vol #:
|
| 1
|
|
| |
|
| 2004V-0155
|
| Valley Forge Composite Technologies Explosive Detection Systems
|
|
|
|
|
| ACK 1
|
| HFA-305 to Valley Forge Composite Technologies
|
| Vol #:
|
| 1
|
|
|
|
|
| VAR
1
|
| Valley Forge Composite Technologies
|
| Vol #:
|
| 1
|
|
