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Dockets Management
Dockets Entered On June 15, 2004
Table of Contents
Docket #  Title
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2003N-0425 Agency Information Collection Activities: Proposed Collection; Comment Request
2003N-0483 Agency Information Collection Activities: Proposed Collection; Comment Request; Food Labeling Regulations
2003N-0542 Agency Information Collection Activities: Proposed Collection; Proposed Collection; Premarket Notification Submission 510(K),
2004M-0253 P980007 - AxSYM Free PSA
2004M-0256 Advanced Bionics; Premarket Approval for Precision Spinal Cord Stimulation (SCS) System; P030017.
2004M-0259 P030045 -IntraStent DoubleStrut Stent
2004M-0260 P010062 - Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
2004N-0017 Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Devices
2004N-0034 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation
2004N-0133 Part 11, Electronic Record; Electronic Signatures; Public Meeting
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
2004N-0245 Current Good Manufacturing Practice Regulations for Medicated Feeds, 21 CFR Part 225
2004N-0258 Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
2004P-0265 Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different than zucapsaicin
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 7174 W. L. Hutchison Vol #: 237
EMC 7175 M. Mitter Vol #: 237
EMC 7176 K. Freeze Vol #: 237
EMC 7177 L- Masters-Lee Vol #: 237
EMC 7178 P. H. Kaplan Vol #: 237
2003N-0425 Agency Information Collection Activities: Proposed Collection; Comment Request
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2003N-0483 Agency Information Collection Activities: Proposed Collection; Comment Request; Food Labeling Regulations
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2003N-0542 Agency Information Collection Activities: Proposed Collection; Proposed Collection; Premarket Notification Submission 510(K),
NAL 1 FDA Vol #: 1
SS 1 Supporting Statement Vol #: 1
2004M-0253 P980007 - AxSYM Free PSA
AAV 1 Abbott Laboratories Vol #: 1
2004M-0256 Advanced Bionics; Premarket Approval for Precision Spinal Cord Stimulation (SCS) System; P030017.
AAV 1 Advanced Bionics Vol #: 1
2004M-0259 P030045 -IntraStent DoubleStrut Stent
AAV 1 ev3, Inc. Vol #: 1
2004M-0260 P010062 - Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
AAV 1 Euclid Systems Corporation Vol #: 1
2004N-0017 Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Devices
N 2 FDA Vol #: 1
2004N-0034 Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Current Good Manufacturing Practice Quality System Regulation
N 2 FDA Vol #: 1
2004N-0133 Part 11, Electronic Record; Electronic Signatures; Public Meeting
EMC 9
Attachment 		AdvaMed Vol #: 2
EMC 10
Attachment 		Hitachi Ltd. Vol #: 2
EMC 11
Attachment 1, 2 		ISPE Vol #: 2
EMC 12
Attachment 		Triangle PEERS Vol #: 2
EMC 13
Attachment 		Johnson & Johnson Vol #: 2
EMC 14 Chiron Corporation Vol #: 2
EMC 15
Attachment 		GXP International Vol #: 2
EMC 16
Attachment 		Animal Health Institute Vol #: 2
EMC 17 Kate Townsend Vol #: 2
EMC 18
Attachment 		Rusco, Inc. Vol #: 2
EMC 19
Attachment 		The Hollis Group, Inc. Vol #: 2
EMC 20
Attachment 		Eli Lilly and Company Vol #: 2
EMC 21
Attachment 		National Food Processors Association (NFPA) Vol #: 2
EMC 22
Attachment 		National Electrical Manufacturers Association (NEMA) Vol #: 2
EMC 23
Attachment 		Genentech Vol #: 2
EMC 24
Attachment 		EduQuest, Inc. Vol #: 2
EMC 25
Attachment 		Wimmer Systems, Inc. Vol #: 2
EMC 26
Attachment 		SEC Associates, Inc. Vol #: 3
EMC 27
Attachment 		PhRMA Vol #: 3
EMC 28
Attachment 		Apotex Inc. Vol #: 3
EMC 29
Attachment 		TECHNIP BioPharm Inc. Vol #: 3
EMC 30
Attachment 		CHPA Vol #: 3
EMC 31
Attachment 		Ursa Logic Corporation Vol #: 3
EMC 32
Attachment 1, 2 		TECHNIP BioPharm Inc. Vol #: 3
EMC 33
Attachment 		Part 11 Coalition Vol #: 3
EMC 34
Attachment 		invivodata, inc. Vol #: 3
EMC 35
Attachment 		Ortho-McNeil Pharmaceutical, Inc. Vol #: 3
EMC 36
Attachment 		KMI Vol #: 3
EMC 37
Attachment 		Cleveland Clinic Foundation Vol #: 3
EMC 38
Attachment 		Infostrength Vol #: 3
EMC 39
Attachment 		Cleveland Clinic Foundation Vol #: 3
2004N-0230 Food; Current Good Manufacturing Practice Regulations; Public Meetings
NM 2 FDA Vol #: 1
2004N-0245 Current Good Manufacturing Practice Regulations for Medicated Feeds, 21 CFR Part 225
N 1 FDA Vol #: 1
2004N-0258 Produce Safety from Production to Consumption: An Action Plan to Minimize Foodborne Illness Associated with Fresh Produce
NM 1 FDA Vol #: 1
2004P-0265 Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different than zucapsaicin
ACK 1 HFA-305 to Winston Laboratories, Inc. Vol #: 1
CP 1 Winston Laboratories, Inc. Vol #: 1

Page created on June 16, 2004 kk

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