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DOCKETS ENTERED on October 2, 2001

TABLE OF CONTENTS

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74P-0001 Vinyl Chloride as ingredient Drug/Cosmetic Aerosol Products *
94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST *
96P-0484 Rotating Membrane Filtration Blood Cell Separation Systems *
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
99P-1864 Reclassify Constrained Hip Prosthesis Metal/Polymer *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0297 Avail. of Info Given to Advisory Committee Members CDRH *
01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA *
01P-0122 To Remove False and Deceptive Labeling for Transderm Scop *
01P-0449 ANDA Suitability for Digoxin Elixir, 0.05 mg/mL *

74P-0001 Vinyl Chloride as ingredient Drug/Cosmetic Aerosol Products

C 4 C. Ruggles Vol#: 1

C 5 Vick Divisions Research Vol#: 1

C 6 The J. B. Williams Company, Inc. Vol#: 1

C 7 American Meat Institute Vol#: 1

C 8 Travenol Laboratories, Inc. Vol#: 1

C 9 The Cosmetic,Toilety & Fragrance Assn. Vol#: 1

C 10 American Meat Institute Vol#: 1

C 11 Ernest D. Eason Vol#: 1

C 12 Union Carbide Corporation Vol#: 1

C 13 E. Fontenot Vol#: 2

C 14 Ernestine Finkins Vol#: 2

C 15 Barbara Talmadge Vol#: 2

C 16 Peter Psaltis Vol#: 2

C 17 Mr. & Mrs. Scott Doup Vol#: 2

C 18 Joseph K. Cooney Vol#: 2

C 19 J. E. Lieb Vol#: 2

C 20 Bristol-Myers Products Vol#: 2

C 21 Abbott Laboratories Vol#: 2

C 22 Jeanne M. Maier Vol#: 2

C 23 Continental Oil Company Vol#: 2

NPR 2 Vol#: 2

94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8563 Garrett Stults Vol#: 116

C 8564 Kate Wilsmann Vol#: 116

C 8565 Allen Salyer Vol#: 116

C 8566 C. Gopinath Vol#: 116

C 8567 Jessica McGinnis Vol#: 116

C 8568 Mary Ann Bergeson Vol#: 116

C 8569 Bill and Judith Bianchi Vol#: 116

C 8570 Eric S. Johnson Vol#: 116

C 8571 Charlie Murdach, MA, A.T.,C. Vol#: 116

C 8572 Amanda C. Goad Vol#: 116

C 8573 Mary Anna Biedermann Vol#: 116

C 8574 Darlene L. Mann Vol#: 116

C 8575 Ruby Fleet Vol#: 116

C 8576 Mrs Leo R. Berger Vol#: 116

C 8577 P.S. Molloy Vol#: 116

C 8578 Lonise Waters Vol#: 116

96P-0484 Rotating Membrane Filtration Blood Cell Separation Systems

PAV 1 HFM-300 to Steven Binion, PhD Vol#: 3

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

C 19 Alpha Therapeutic Corporation Vol#: 1

C 20 San Diego Blood Bank Vol#: 1

C 21 New York Blood Center Vol#: 1

C 22 Blood Systems, Inc. Vol#: 1

EXT 5 Sera-Tec Biologicals Vol#: 1
 
 

EXT 6 Nabi Vol#: 1

99P-1864 Reclassify Constrained Hip Prosthesis Metal/Polymer

C 1 Biomet Vol#: 3

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9499 Form Letter count 2,038 Vol#: 508

C 9500 Tamara Ellen-Hess Shields Vol#: 476

C 9501 Form Letter Count 1,411 Vol#: 509

C 9502 Form Letter Count 10 Signatures Vol#: 512

C 9503 Form Letter Count 6,560 Signatures Vol#: 513

C 9504 Form Letter count 120 Vol#: 514

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

N 1 Vol#: 1

00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated

LET 1 HF-40 to Representive Bonnie Ladwig Vol#: 1

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

C 26 National Farmers Union Vol#: 2

00P-1322 Food Labeling and Allergen Contamination Control

C 412 Lisa M. Scott Vol#: 25

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

C 183 John J. Kravitz, MD, F.A.C.G. Vol#: 5

01D-0297 Avail. of Info Given to Advisory Committee Members CDRH

C 2 Allergan, Inc. Vol#: 1

01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA

C 5 Bayer Corporation Vol#: 1

C 6 Levin, Fishbein, Sedran & Berman Vol#: 1

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

N 1 Vol#: 1

01N-0384 Global Harmonization task Force Conference in Spain

N 1 Vol#: 1

01P-0122 To Remove False and Deceptive Labeling for Transderm Scop

C 2 Novartis Consumer Health, Inc. Vol#: 2

01P-0449 ANDA Suitability for Digoxin Elixir, 0.05 mg/mL

ACK 1 HFA-305 Vol#: 1

CP 1 Roxane Laboratories, Inc. Vol#: 1