Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on September 6, 2001

TABLE OF CONTENTS

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95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97P-0130 Require Percentage Ingredient Labeling *
98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC *
01P-0394 ANADA generic equivalent of innovator product Heartgard 30 *

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 96 Roche Vitamins Inc Vol#: 70

97P-0130 Require Percentage Ingredient Labeling

C 125 Virginia Hohenstein Vol#: 5

C 126 Erin Seager Vol#: 5

C 127 Judge Henry X. Dietch (Ret) Vol#: 5

C 128 Jessica Smith Vol#: 5

C 129 Alicia Sanchez Vol#: 5

C 130 Frederick J. Sigur, Jr. Vol#: 5

98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

C 40 Provider Service Network Vol#: 5

99P-1864 Reclassify Constrained Hip Prosthesis Metal/Polymer

NPR 1 Vol#: 3

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 8972 Form Letter Count 17 Vol#: 339

C 8973 Form Letter Count 12 Vol#: 340

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

C 174 Donald A. O'Kieffe, M.D. Vol#: 5

C 175 Laurence R. Plumb, M.D. Vol#: 5

C 176 Philip M. Palmerson, Jr. BA,BS, RPh Vol#: 5

C 177 Gerald L. Guillory, M.D. Vol#: 5

C 178 Stefan P. Marcuard, MD, FACP Vol#: 5

01D-0318 Joint Metal/Polymer Constrained Cemented or Uncemented Prosh

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

01M-0380 P830039/S007; Omnicarbon Cardiac Valve Prosthesis

AAV 1 Medical CV, Inc. Vol#: 1

01M-0381 Edwards Prima Plus Stentless Bioprosthesis Model 2500P

AAV 1 Edwards Lifesciences LLC Vol#: 1

01P-0394 ANADA generic equivalent of innovator product Heartgard 30

CP 1 ECO LLC Vol#: 1

01V-0393 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Ace Mitchell Bowler's Mart Vol#: 1