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 5, 2001

TABLE OF CONTENTS

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91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0232 Reprocessing/Reuse of Single-Use Devices for Industry/FDA *
01N-0359 Proposal to Debar Craig H. Petrik; NPH *
01P-0389 Revoke CPG 7383.003 for Class III 510(k) Devices Pre-amend *
01Q-0352 Health claim notification for foods containing choline based *

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

LET 8 HFS-800 to Emord & Associates P C Vol#: 101

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2208 Janet Meirelles, RN, CDE Vol#: 64

C 2209 Ruth N. Albrecht Vol#: 64

EMC 510 Jeanne W. Lawless, PhD Vol#: 64

EMC 511 Susan Ruiz Vol#: 64

EMC 512 Susan Ruiz Vol#: 64

EMC 513 Susan Ruiz Vol#: 64

EMC 514 Elaine DeFelix Vol#: 64

LET 19 HFS-24 Vol#: 64

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

GDL 4 Guideline Vol#: 1

NAD 4 Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9406 C. Erdey Vol#: 465

C 9407 Margaret Kaye Vol#: 465

C 9408 Nathaniel Whitmore Vol#: 465

C 9409 Center for Food Safety et al Vol#: 465

C 9410 M. Hagens Vol#: 465

C 9411 Lori David Vol#: 465

C 9412 Terry Poplawski Vol#: 465

C 9413 Tania Banak Vol#: 465

C 9414 Barry G. Lindsey Vol#: 465

C 9415 Leanne Barker Vol#: 465

C 9416 No Signature Vol#: 465

C 9417 J. Just Vol#: 465

C 9418 Judy Just Vol#: 465

C 9419 Catherine Sutton Vol#: 465

C 9420 Bhanu Shah Vol#: 465

C 9421 Diane & Chris Abell Vol#: 465

C 9422 Lana L & Dan Keating Vol#: 465

C 9423 Mary A. Hoven Vol#: 465

C 9424 Jean McKay Vol#: 465

C 9425 Becky Harris Vol#: 465

C 9426 Kathleen Meyers Vol#: 465

C 9427 Nathaniel Whitmore Vol#: 465

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 8956 Tania Banak Vol#: 332

C 8957 Jean McKay Vol#: 332

C 8958 Center for Food Safety et al Vol#: 332

C 8959 Elmer H. Coffelt Vol#: 332

C 8960 J. Just Vol#: 332

C 8961 Judy Jest Vol#: 332

C 8962 Catherine J. Sutton Vol#: 332

C 8963 Bhanu Shah Vol#: 332

C 8964 Diane & Chris Abell Vol#: 332

C 8965 Lana L. & Dan Keating Vol#: 332

C 8966 Elizabeth A. Graser-Lindsey Vol#: 332

C 8967 Leanne Barker Vol#: 332

C 8968 Number not used Vol#: 332

C 8969 Becky Harris Vol#: 332

C 8970 Kathlyn Meyers Vol#: 332

C 8971 Nathaniel Whitmore Vol#: 332

00P-1322 Food Labeling and Allergen Contamination Control

ANS 3 HFW-14 to Heidi Hagler Vol#: 23

ANS 4 HFW-14 to Joseph I Lieberman (CI) Vol#: 23

ANS 5 HFW-14 to Jon S Corzine (CI) Vol#: 23

C 343 Charles R Smith Vol#: 23

C 344 Sarah Rawlinson Vol#: 23

C 345 Sondra J Hall Vol#: 23

C 346 Ivy A Petersen MD Vol#: 23

C 347 U V Henderson Vol#: 23

C 348 Bonnie Lathrop Vol#: 23

TR 1 Labeling Food Allergens Transcript Vol#: 24

01D-0232 Reprocessing/Reuse of Single-Use Devices for Industry/FDA

C 3 American Assn. of Orthopaedic Surgeons Vol#: 1

01D-0286 In Vitro HIV Drug Resistance Genotype Assays [510(k)s]

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

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

C 168 Bethesda-Chevy Chase Orthopaedic Associa Vol#: 6

C 169 Paula T Williams Vol#: 6

C 170 Sharon Newman Vol#: 6

C 171 NaSA Neuroscience & Spine Associates Vol#: 6

C 172 Daniel J Melock Vol#: 6

C 173 Charles Cicotella Vol#: 6

C 174 B Eliot Cole MD MPA Vol#: 6

C 175 Northside Hospital & Heart Institute Vol#: 6

C 176 Louis Reznick DOPC Vol#: 6

C 177 College on Problems of Drug Dependence I Vol#: 6

C 178 Arthur J Vayer Jr MD Vol#: 6

C 179 Harriet E Bradshaw Vol#: 6

C 180 Kimberley L Rosenstein Vol#: 6

C 181 Palliative Care Strategies Vol#: 6

C 182 Precision Orthopaedic Specialties Inc Vol#: 6

C 183 Patrick H Kelly Vol#: 6

C 184 PrimeCare Medicine Associates Vol#: 6

C 185 Marcia J Greenshields Vol#: 6

C 186 Carla B Nees Vol#: 6

C 187 Andy Nees Vol#: 6

C 188 Jamy Rosenstein Vol#: 6

C 189 Blair Hurst Vol#: 6

C 190 Gynile E Gregg Vol#: 6

C 191 Windham Medical Group PC Vol#: 6

C 192 Hon Bob Smith (Seacoast Hospice) Vol#: 6

C 193 American Society of Interventional Pain Vol#: 7

C 194 The Children's Hospital of Philadelphia Vol#: 7

C 195 Lee and Sandra Tucci Vol#: 7

C 196 Interventional Pain Management Medical G Vol#: 7

C 197 Kathleen M Donara MS Vol#: 7

C 198 Katherine L DeCarlo Vol#: 7

C 199 Elizabeth M Danahy Vol#: 7

C 200 Owensboro Pediatrics, Pediatric & Adoles Vol#: 7

C 201 Carilion Family Medicine Vol#: 7

C 202 Timothy Hoffmann MD Vol#: 7

C 203 Lassen Medical Group Inc Vol#: 7

C 204 Hospice & Palliative Nurses Association Vol#: 7

C 205 William L Marcu Vol#: 7

C 206 DeWitt E Kemp III MD Vol#: 7

C 207 Spine & Pain Center Vol#: 7

C 208 Center for Neurology & Pain Management Vol#: 7

C 209 D M Jarrott A Professional LLC Vol#: 7

C 210 Stephen J Halpern MD Vol#: 7

C 211 Charlotte Bombere Vol#: 7

C 212 Leigh D Reichert Vol#: 7

C 213 Hoffman & Associates Vol#: 7

C 214 Charles S Eytel MD Vol#: 7

C 215 American Cancer Society Vol#: 7

C 216 American Pharmaceutical Association Vol#: 7

C 217 Forensic & Educational Consultants Vol#: 7

C 218 Pain Care & Neeurology Center Vol#: 7

C 219 David E Nees Vol#: 7

C 220 Stephen J Halpern MD Vol#: 7

C 221 Mark W Peterson MD Vol#: 7

C 222 Orthopaedic Associates Vol#: 7

C 223 Eastern Shore Neurology & Pain Clinics Vol#: 7

C 224 Cathy C Asche RN BSN Vol#: 7

C 225 Dennis Houghton Vol#: 7

C 226 Walter H Jacobs MD Vol#: 7

C 227 NJ Aesthesia Center for Pain Mediicine Vol#: 7

C 228 Medtronic Inc Vol#: 7

C 229 Ronald H Bradley DO PhD Vol#: 7

C 230 Dennis B Lind MD Vol#: 7

C 231 Alan W Richardson Vol#: 7

C 232 William H Moss Jr Vol#: 7

C 233 Schnepp Health Care Center Vol#: 7

C 234 Paige Thorpe Vol#: 7

C 235 Number not used Vol#: 7

C 236 Pinellas Physiatry Associates Vol#: 7

C 237 Orange County Neurological Medical Group Vol#: 7

C 238 Number not used Vol#: 7

C 239 James P Royce Vol#: 7

C 240 Riverview Family Medicine Vol#: 7

C 241 Connecticut Hospice Inc Vol#: 7

C 242 Clara Mays Vol#: 7

C 243 American Chronic Pain Association Suppor Vol#: 7

C 244 Keith L Hindman DO Vol#: 7

C 245 Susan Wolf Vol#: 7

C 246 Mays & Schnapp Pain Clinic Vol#: 7

C 247 Granite State Osteopathic Physicians Vol#: 7

C 248 Caleb Trainer Vol#: 7

C 249 Conrad H Daum MD Vol#: 7

C 250 Deborah Golemviewski Vol#: 7

C 251 Suzanne M L Motyka Vol#: 7

C 252 Ear, Nose & Throat Associates Vol#: 7

C 253 Palmetto Hematology Oncology PC Vol#: 7

C 254 Thomas A O'Connell Vol#: 7

C 255 Mrs. Emery Mays Vol#: 7

C 256 Carol A Ferguson Vol#: 7

C 257 Arlington Family Health Pavillon PA Vol#: 7

C 258 Arlington Family Health Pavillon PA Vol#: 7

C 259 A J Morris MD PA Vol#: 7

C 260 Judith Townsend Vol#: 7

C 261 June Gatti Vol#: 7

C 262 Kenneth J Campbell Vol#: 7

C 263 Mary Jane Poloncarz Vol#: 7

C 264 Kate Candee + 3 others Vol#: 7

C 265 Jimmy Johnson + 8 others Vol#: 7

C 266 Pauline Sturch + 8 others Vol#: 7

C 267 Ricky Newt Vol#: 7

C 268 Mary Moline Vol#: 7

C 269 Alaska Pain Network Vol#: 7

C 270 American Society of Perianesthesia Nurse Vol#: 7

C 271 Number not used Vol#: 7

C 272 Lisa Capaldini MD Vol#: 7

C 273 Deborah Page Vol#: 7

C 274 Thomas J Grimaldi Vol#: 7

C 275 Steven W Harrison MD Inc Vol#: 7

C 276 Center for Spine Sports & Pain Managemen Vol#: 7

C 277 Number not used Vol#: 7

C 278 Karen D Mellish Vol#: 7

C 279 Portsmouth Regional Hospital Vol#: 7

C 280 Number not used Vol#: 7

C 281 Ann M Nyitrai Vol#: 7

NM 1 Meeting September 13-14, 2001 Vol#: 6

01N-0359 Proposal to Debar Craig H. Petrik; NPH

LET 1 HFM-17 Vol#: 1

01P-0389 Revoke CPG 7383.003 for Class III 510(k) Devices Pre-amend

ACK 1 HFA-305 Vol#: 1

CP 1 Kyper & Associates LLC Vol#: 1

01Q-0352 Health claim notification for foods containing choline based

ACK 1 HFS-832 to Central Soya Co., Inc. Vol#: 1

HCN 1 Central Soya Co., Inc. Vol#: 1

01V-0390 Variance for Q-Beam Series Q-40(RG)(MC), Q-100, Q-150, Q-175

ACK 1 HFA-305 Vol#: 1

VAR 1 Kustom Sounds Kauai Vol#: 1

01V-0391 Variance for Q-Beam series Q-40(RG)(MC), Q-100G, Q-150G, Q17

ACK 1 HFA-305 Vol#: 1

VAR 1 Luner's Santa Barbara Vol#: 1