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DOCKETS ENTERED on September 12, 2001

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants *
98N-1038 Irradiation in the production, processing, &handling of food *
99P-5198 Request amendment of the definition of milk *
99P-5589 Reclassification of Absorbable Polydioxanone Surgical Suture *
00D-1033 Clinical Trials for Serious/Life-Threatening Diseases *
00N-0989 Human Gene Therapy *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1550 Approve ANDA for Cefuroxime Axetil Products *
01D-0171 Content of Premarket Notifications for Automated Blood Separ *
01P-0010 The Use of Cardura for the Treatment of Hypertension *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
76N-052N OTC Nasal Decongestants

EMC 117 Susan S McCarthy Vol#: 76

EMC 118 Bobbin Yarbrough Vol#: 76

98E-0852 Patent Extension # 5,298,520 MAXALT (rizatriptan Benzoate)

LET 3 HFD-5 to U S Patent & Trademark Office Vol#: 1

98N-0581 Requirements for Testing Human Blood Donors

NAL 1 Vol#: 5

SS 1 SPPORTING STATEMENT Vol#: 5

98N-0607 General Requirements for Blood,Blood Components and Derivati

NAL 1 Vol#: 2

SS 1 SUPPORTING STATEMENT Vol#: 2

98N-1038 Irradiation in the production, processing, &handling of food

C 5471 Organic Consumers Assn. Vol#: 172

C 5472 Amy Vose Vol#: 172

C 5473 Carol Bussord Vol#: 172

C 5474 Celia de Lavallade Vol#: 172

C 5475 Beco, Inc. Vol#: 172

C 5476 Ms. Helen Garrison Vol#: 172

C 5477 Frank & Arlene Guerra Vol#: 172

C 5478 Mary Lou Herman Vol#: 172

C 5479 Ruth Louise Granick Vol#: 172

C 5480 Kate Garrison Vol#: 172

C 5481 Marvin Miller Vol#: 172

C 5482 Becky Eisenstein Vol#: 172

99P-5198 Request amendment of the definition of milk

LET 2 American Dairy Products Institute Vol#: 1

99P-5589 Reclassification of Absorbable Polydioxanone Surgical Suture

PAV 1 HFZ-400 to Ethicon, Inc. Vol#: 1

00D-1033 Clinical Trials for Serious/Life-Threatening Diseases

C 6 CenterWatch Vol#: 1

C 7 PhRMA Vol#: 1

00E-1250 Patent Extension Synercid #4,798,827

LET 2 HFD-t to U S Department of Patent & Trad Vol#: 1

00E-1251 Patent Extension Synercid #4,668,669

LET 2 HFD-t to U S Department of Patent & Trad Vol#: 1

00N-0989 Human Gene Therapy

C 138 N C Scheuermann Vol#: 8

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 8987 Tina Moody Vol#: 332

C 8988 Karen E. Neill Vol#: 332

C 8989 Marilyn R. Parks Vol#: 332

C 8990 Michelle Stuckey Vol#: 332

C 8991 Angela Medbery Vol#: 332

C 8992 Ruth Prinz Vol#: 332

C 8993 David McLean Vol#: 332

C 8994 Julie L. Rand Vol#: 332

C 8995 E. Boom Vol#: 332

C 8996 Susan Anderson Vol#: 332

C 8997 A. Ling Vol#: 332

C 8998 Richie Brown Vol#: 332

C 8999 Tara Chacal Vol#: 332

C 9000 Illegible Vol#: 332

C 9001 Robert E. Fisher Vol#: 332

C 9002 Robin L. Swanson Vol#: 332

C 9003 Lucinda Simpson Vol#: 332

C 9004 Barbara S. Evans Vol#: 332

C 9005 Angela Medbery Vol#: 332

C 9006 Geoffrey Tudor Vol#: 332

C 9007 Craig Appel Vol#: 332

C 9008 Lydia Blanchard Vol#: 332

C 9009 John E. Tanner, Jr. Vol#: 332

C 9010 James Manley Vol#: 332

C 9011 Ecology Center Vol#: 332

C 9012 Janet Glass Vol#: 332

C 9013 E. Margaret Kenepp Vol#: 332

C 9014 Susan Long Vol#: 332

C 9015 Bethany Nagy Vol#: 332

C 9016 Peter J. Kelly & Ellen Braun-Kelly Vol#: 332

00P-1499 Remove alosetron (Lotronex) from the market

C 179 Rocky Mountain Gastroenterology Associat Vol#: 5

00P-1550 Approve ANDA for Cefuroxime Axetil Products

SUP 4 GlaxoSmith Kline Vol#: 2

01D-0171 Content of Premarket Notifications for Automated Blood Separ

LET 1 HFM-10 to Adva Med Vol#: 1

01E-0029 Patent Extension for Trileptal, No. 4,559,174

LET 3 HFD-t to U S Department of Patent & Trad Vol#: 1

01E-0089 Kaletra, Patent Extension Application No.5,886,036

LET 3 HFD-t to U S Department of Patent & Trad Vol#: 1

01E-0090 Abreva, Patent Extension Application No.4,874,794

LET 3 HFD-t to U S Department of Patent & Trad Vol#: 1

01E-0092 Rescula, Patent Extension Application No. 5,221,763

LET 3 HFD-t to U S Department of Patent & Trad Vol#: 1

01E-0093 Melon Z Rigid Gas Permeable Contact Lens, Patent Extension

LET 2 HFD-t to U S Department of Patent & Trad Vol#: 1

01E-0096 Dantochlor RW/Dantobrom RW, Patent Extension Application

LET 2 HFD-t to U S Department of Patent & Trad Vol#: 1

01E-0098 TNKase, Patent Extension Application No.5,385,732

LET 3 HFD-t to U S Department of Patent & Trad Vol#: 1

01E-0099 Menicon Z Rigid Contact Lens, Patent Extension Application

LET 2 HFD-t to U S Department of Patent & Trad Vol#: 1

01E-0213 Angiomax, Patent Term Extension Application, No. 5,196,404

LET 2 HFD-t to U S Department of Patent & Trad Vol#: 1

01N-0069 Information From U.S. Processors That Export to European Cmt

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

01N-0153 Voluntary Registration of Cosmetic Product Esstablishments

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

01N-0154 Color Additive Certification Request and Recordkeeping

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

01N-0231 Verterinary adverse drug reaction, lack of effect, product

NEC 1 Vol#: 1

01N-0249 Consumer and Producer Surveys on Economic Issues

N 2 Vol#: 1

01N-0370 Progress on implementing for the common technical document

NM 1 Vol#: 1

01P-0010 The Use of Cardura for the Treatment of Hypertension

MT 1 HFD-110 & S Graziano, Milberg Weiss Bers Vol#: 2

MT 2 HFD-110 & J Picciano, S LoGalbo, Pfizer Vol#: 2

MT 3 HFD-110 & J Picciano, S LoGalbo, Pfizer Vol#: 2

MT 4 HFD-110 & S Graziano, T Parr Vol#: 2

MT 5 HFD-110 & J Picciano, S LoGalbo, Pfizer Vol#: 2

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

LET 2 HFD-1 to Center for Reproductive Law & P Vol#: 10

01V-0273 Laser Light Show

VRA 1 HFZ-340 to Forum Night Club, Inc. Vol#: 1

01V-0282

VRA 1 HFZ-340 to Friends Landing Vol#: 1

01V-0300 Laser light show

VRA 1 HFZ-340 to Mr. John A. Holder Vol#: 1

01V-0324 Laser Light Show Mobolazer ML8-20G,Ml8-50RG,ML10-250,

VRA 1 HFZ-340 to Midwest Sound & Light Vol#: 1

01V-0330 Laser Light Show

VRA 1 HFZ-340 to The Grid Vol#: 1