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 December 14, 2001

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants *
90N-0275 Conjugated Estrogens Tablets Proposal to Refuse Five (NADA' *
90P-0081 PREMARIN label be declared as false and misleading *
94P-0429 Establish the Proper Composition of Conjugated Estrogens *
94P-0430 Stay of Action of Approval of ANDAs for Conjugated Estrogens *
97N-0325 Conjugated Estrogens Tablets *
98N-1265 Distribution of Compounded Drug Products *
98P-0504 Raw Molluscan Shellfish of Undetectable Levels *
99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu *
99N-2079 Assessment of Preclinical Reproductive Toxicity Data *
99P-1340 Declared Eternity eau de Parfum Misbranded *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01N-0476 Electronic Interchange Standard for Digital ECG; Public Meet *
01N-0496 Patient Profile Viewer *
76N-052N OTC Nasal Decongestants

EMC 123 Judy McCollum Vol#: 76

90N-0275 Conjugated Estrogens Tablets Proposal to Refuse Five (NADA'

LET 3 HFD-005 to Barr Labs., Inc. Vol#: 1

90P-0081 PREMARIN label be declared as false and misleading

LET 4 HFD-005 to Barr Laboratories Vol#: 1

94P-0429 Establish the Proper Composition of Conjugated Estrogens

LET 3 HFD-005 to Wyeth-Ayerst Laboratories Vol#: 22

94P-0430 Stay of Action of Approval of ANDAs for Conjugated Estrogens

LET 2 HFD-005 to Wyeth-Ayerst Laboratories Vol#: 1

97N-0325 Conjugated Estrogens Tablets

LET 1 HFD-005 to Barr Labs. Inc Vol#: 9

LET 2 HFD-005 to Barr Labs. Inc Vol#: 9

98N-0337 Over the counter human drugs labeling requirements

ANS 12 HFD-56 to L Perrigo Company Vol#: 8

WDL 2 Novex Pharma Vol#: 8

98N-1265 Distribution of Compounded Drug Products

EMC 1 Dianne Otero Vol#: 174

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

EMC 52 Francisco Costa Vol#: 28

EMC 53 E. Karsten Smelser Vol#: 28

EMC 54 Greg Reynolds Vol#: 28

EMC 55 Regina Holt Vol#: 28

EMC 56 Timothy Stebler Vol#: 28

EMC 57 Karen Svonkin Vol#: 28

EMC 58 Kyle Richardson Vol#: 28

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 101 Center for Food Safety Vol#: 2

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 4 Center for Food Safety Vol#: 2

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 4 Center for Food Safety Vol#: 1

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 6 Center for Food Safety Vol#: 1

99N-2079 Assessment of Preclinical Reproductive Toxicity Data

C 5 Ronald D. Hood & Associates Vol#: 3

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 349 Kathy Fitzgerald Vol#: 18

EMC 350 Cherrie L. Clausen Vol#: 18

EMC 351 Mary Kempf Vol#: 18

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 11843 No signature Vol#: 426

EMC 11844 JC Hwang Vol#: 426

EMC 11845 Paul Shaia Vol#: 426

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 11527 JC Hwang Vol#: 349

EMC 11528 Paul Shaia Vol#: 349

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 186 Lisa Taylor Lake Vol#: 25

C 187 Dayna Wolter Vol#: 25

C 188 John Streed Vol#: 25

C 189 Anne M. Carlson Vol#: 25

00P-1322 Food Labeling and Allergen Contamination Control

EMC 453 Evelyn Houghtaling Vol#: 20

EMC 454 B. Naylor Vol#: 20

EMC 455 Barbara Graham Vol#: 20

EMC 456 Brenda Rodenburgh Vol#: 20

EMC 457 Tina Degati Vol#: 20

EMC 458 Heather Wickham Vol#: 20

EMC 459 Melanie Haveron Vol#: 20

EMC 460 Alison Kearns Vol#: 20

EMC 461 CSPI Vol#: 20

01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm

EMC 1 Thomas A. Louis, PhD Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EMC 192 Dan Pearce Vol#: 2

01N-0397 Transportation Safety & Potentially Sedating or Impairing

EMC 2 Citizens Against Drug Impaired Drivers Vol#: 2

EMC 3 Citizens Against Drug Impaired Drivers Vol#: 2

01N-0476 Electronic Interchange Standard for Digital ECG; Public Meet

EMC 1 Polina Voloshko, MD Vol#: 1

01N-0496 Patient Profile Viewer

C 1 Pfizer, Inc. Vol#: 1

EMC 1 Sarah Shiue Vol#: 1

01V-0568 Laser Light Show

VAR 1 Theatrix Inc. Vol#: 1