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 4, 2000

TABLE OF CONTENTS

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89P-0505 Prescription Drug Advertisements Directed to Consumers *
97N-0436 Methods informing consumers of contents of bottle water *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-1340 Declared Eternity eau de Parfum Misbranded *
00D-1385 Investigational Device Exemption (IDE's) & (PMA) *
00P-1648 Electrode Lead Wires and Patient Cables *

89P-0505 Prescription Drug Advertisements Directed to Consumers

EMC 1 Paul Kimpel & Maria Soler Vol#: 1

EMC 2 Jose M. Catasus Vol#: 1


97N-0436 Methods informing consumers of contents of bottle water

EMC 70 Sheila McCanna Vol#: 7

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 6134 Health Smart Vitamins Vol#: 49

LET 6135 Country Life Vol#: 49

LET 6136 Twin Laboratories, Inc. Vol#: 49

LET 6137 NBTY Vol#: 49

LET 6138 Country Life Vol#: 49

LET 6139 Country Life Vol#: 49

LET 6140 Country Life Vol#: 49

LET 6141 Chinese Herb Center, Inc. Vol#: 49

LET 6142 Health Smart Vitamins Vol#: 49

LET 6143 Health Smart Vitamins Vol#: 49

LET 6144 Health Smart Vitamins Vol#: 49

LET 6145 Watt Health Vol#: 49

LET 6146 NBTY Vol#: 49

LET 6147 NBTY Vol#: 49

LET 6148 NBTY Vol#: 49

LET 6149 NBTY Vol#: 49

LET 6150 NBTY Vol#: 49

LET 6151 NBTY Vol#: 49

LET 6152 NBTY Vol#: 49

LET 6153 NBTY Vol#: 49

LET 6154 NBTY Vol#: 49

LET 6155 NBTY Vol#: 49

LET 6156 NBTY Vol#: 49

LET 6157 NBTY Vol#: 49

LET 6158 NBTY Vol#: 49

LET 6159 Haussler Nutritionals Vol#: 49

LET 6160 Institue For Alternative Health, Ltd. Vol#: 49

LET 6161 Standard Process Vol#: 49

LET 6162 Standard Process Vol#: 49

LET 6163 Standard Process Vol#: 49

LET 6164 Standard Process Vol#: 49

LET 6165 Standard Process Vol#: 49

LET 6166 Standard Process Vol#: 49

LET 6167 Country Life Vol#: 49

LET 6168 Country Life Vol#: 49

LET 6169 Twin Laboratories, Inc. Vol#: 49

LET 6170 Chinese Herb Center, Inc. Vol#: 49

LET 6171 Tom's of Maine Vol#: 49

LET 6172 NBTY Vol#: 49

LET 6173 Fitness Labs Nutrition Corporation Vol#: 49

LET 6174 Fitness Labs Nutrition Corporation Vol#: 49

LET 6175 Fitness Labs Nutrition Corporation Vol#: 49

LET 6176 Fitness Labs Nutrition Corporation Vol#: 49

LET 6177 Fitness Labs Nutrition Corporation Vol#: 49

LET 6178 Fitness Labs Nutrition Corporation Vol#: 49

LET 6179 Fitness Labs Nutrition Corporation Vol#: 49

LET 6180 Fitness Labs Nutrition Corporation Vol#: 49

LET 6181 Fitness Labs Vol#: 49

LET 6182 Merck Vol#: 49

LET 6183 Starlight International Vol#: 49

LET 6184 Starlight International Vol#: 49

LET 6185 Country Life Vol#: 49

LET 6186 Zenith Goldline Pharmaceuticals Vol#: 49

LET 6187 Pharmavite Corporation Vol#: 49

LET 6188 Pharmavite Corporation Vol#: 49

LET 6189 Country Life Vol#: 49

LET 6190 Country Life Vol#: 49

LET 6191 Country Life Vol#: 49

LET 6192 Country Life Vol#: 49

LET 6193 Country Life Vol#: 49

LET 6194 Country Life Vol#: 49

LET 6195 Country Life Vol#: 49

LET 6196 Pharmavite Corporation Vol#: 49

LET 6197 Pharmavite Corporation Vol#: 49

LET 6198 Pharmavite Corporation Vol#: 49

LET 6199 Pharmavite Corporation Vol#: 49

LET 6200 Pharmavite Corporation Vol#: 49

LET 6201 Pharmavite Corporation Vol#: 49

LET 6202 Pharmavite Corporation Vol#: 49

LET 6203 Pharmavite Corporation Vol#: 49

LET 6204 Country Life Vol#: 49


98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 3131 Joann L. Spray Vol#: 94

C 3132 Charlotte B. Montgomery Vol#: 94

C 3133 Marie S. Sequeira Vol#: 94

C 3134 Joan C. Schuch Vol#: 94

C 3135 Ms. Joan Miller Vol#: 94

C 3136 Barbara Berger Vol#: 94

C 3137 Steve Karian Vol#: 94

C 3138 Laurel Tinney Vol#: 94

C 3139 Ms. Peggy Spiegel Vol#: 94

C 3140 Matthew Judd McGuire Vol#: 94

EMC 442 Susan Hughes Vol#: 94

EMC 443 RoseMarie & Gina Tubertini Vol#: 94

EMC 444 Kathy Weeks Vol#: 94

EMC 445 Janna S. Sipes Vol#: 94

EMC 446 Deirdre Larkin Vol#: 94

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 198 Nancy L. Speer Vol#: 16


00D-1385 Investigational Device Exemption (IDE's) & (PMA)

C 3 Bausch & Lomb, Inc. Vol#: 1

00D-1595 Recommendations for Complying with the Pediatric Rule

GDL 1 Guidance for Industry Vol#: 1

NAD 1 Guidance for Industry Vol#: 1

00D-1601 Guidance for Industry and for FDA Employees on Import Alert

GDL 1 Guidance fo FDA Staff Vol#: 1

NAD 1 Vol#: 1

00N-1609 Digoxin Products for Oral Use; new drug status/conditions

N 2 Vol#: 1

00N-1610 Digoxin Products Oral Use;Revocation conditions marketing

NPR 1 Vol#:

00N-1639 Withdrawal of Approval of an ANDA; Cyclosporine

BKG 1 Background Material Vol#: 1

NWL 1 Vol#: 1

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

NIR 2 Vol#: 12

00P-1276 Health Claim: Plant stanol esters and heart disease

NIR 2 Vol#: 11

00P-1648 Electrode Lead Wires and Patient Cables

ACK 1 HFA-305 Vol#: 1

CP 1 NeuroControl Corporation Vol#: 1

00V-1647 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Lumatech Lighting Vol#: 1