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DOCKETS ENTERED on December 18, 2000

TABLE OF CONTENTS

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94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
95S-0117 Human Drugs Patent Term Extension & New Patents *
97N-484S Human Cellular and Tissue-Based Products *
98F-0165 safe use of ionizing radition for reduction of salmonella *
98N-0331 Medical Devices;Implementation third party review under FDA *
99P-1340 Declared Eternity eau de Parfum Misbranded *
00D-1555 Refusal of Inspection or Access to HACCP recods pertaining *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1330 Regulation approving the dosage approved for drug Propecia *
00P-1340 Withdrawn of ROWASA Suppositories *
00P-1369 Prohibit Making an Unapproved Health Claim *
00P-1519 ANADA for a generic new animal drug/Heartgard chewable tblts *

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

EMC 489 Hope Tiktin Vol#: 64

95S-0117 Human Drugs Patent Term Extension & New Patents

LST 58 List as of December 13, 2000 Vol#: 4

97N-0511 Procedures the safe and sanitary processing/importing juice

C 768 Safe Food Coalition Vol#: 31

97N-484S Human Cellular and Tissue-Based Products

C 496 Eye Bank Association of America Vol#: 27

98F-0165 safe use of ionizing radition for reduction of salmonella

HER 9 Eric J. George Vol#: 2

98N-0331 Medical Devices;Implementation third party review under FDA

C 11 OSMA, Orthopaedic Surgical Mfrs Assn. Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 204 Nancy Vol#: 16

00D-1555 Refusal of Inspection or Access to HACCP recods pertaining

C 1 ESI Qual International Vol#: 1

00D-1629 VICH GL20 & VICH GL21

GDL 1 Guidance for Industry Vol#: 1

GDL 2 Guidance for Industry Vol#: 1

NAD 1 Vol#: 1

00D-1631 Genotoxicity Studies (VICH GL23)

GDL 1 Guidance for Industry Vol#: 1

NAD 1 Vol#: 1

00D-1632 Management of Adverse Event Reports (AER's) (VICH GL24)

GDL 1 Guidance for Industry Vol#: 1

NAD 1 Vol#: 1

00H-1242 Civil Money Penalty;Laser Vision Centers Inc. et al

MO 10 Laservision Ctrs. Inc. & GCF-1 Vol#: 2

00N-1303 Agreement for Shipment of Devices for Sterilization

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00N-1328 Latex Condoms; User labeling;Expiration Dating

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00N-1353 CGMP & Related Regs for Blood & Blood Components;Information

NAL 1 Vol#: 1

00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs

C 23 Center for Medical Consumers Vol#: 2

00N-1359 Collection of information: Affirmation of (GRAS) Status

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00N-1586 Licensed Anti-Human Globulin and Blood Grouping Reagents

NFR 1 Vol#: 1

NPR 1 Vol#: 1

00N-1642 Establishment Registration and Listing Requirements for Huma

NAD 1 Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 7578 Form Letter Count 7 Vol#: 368

C 7579 Form Letter Count 1 Vol#: 369

C 7580 Form Letter Count 2 Vol#: 370

C 7581 Form Letter Count 6 Vol#: 371

C 7582 Form Letter Count 2 Vol#: 372

C 7583 Form Letter Count 10 Vol#: 373

00P-1322 Food Labeling and Allergen Contamination Control

C 5 Grocery Manufacturers of America Vol#: 2

00P-1330 Regulation approving the dosage approved for drug Propecia

PAV 1 HFD-1 to University of Pennsylvania Vol#: 1

00P-1340 Withdrawn of ROWASA Suppositories

LET 1 HFD-1 to Able Laboratories, Inc. Vol#: 1

00P-1369 Prohibit Making an Unapproved Health Claim

PDN 1 HFC-1 to CSPI Vol#: 1

00P-1519 ANADA for a generic new animal drug/Heartgard chewable tblts

PAV 1 HFV-100 to Smart Drug Systems, Inc. Vol#: 1

00P-1623 WDL of letter issued regarding product Misoprostol

EMC 1 Form Letter Vol#: 2

00V-1673 Request for Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 The DJ Store Vol#: 1