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DOCKETS ENTERED on October 12, 2001

TABLE OF CONTENTS

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97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1296 Importation of Pasteurized Milk Ordinance (PMO) *
00D-1393 Screening tests labeled for use w/ Cadaveric blood Specimens *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1510 Establish safety of Echinacea extract as a GRAS pharmaceutic *
01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled *
01D-0281 Proposed Globally Harmonized Alternative for PMA Procedures *
01D-0297 Avail. of Info Given to Advisory Committee Members CDRH *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *

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

EC 9 Alpha Therapeutic Corporation Vol#: 3

EC 10 Mr. Richard Mecchi-Ericson Vol#: 3

98D-1169 Format for Geriatric Labeling

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

EC 8 Mrs. Trella Shores Vol#: 25

EC 9 Security Foods & Supplies Vol#: 25

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 3216 Mr & Mrs Max Weaver Vol#: 210

C 3217 S. Frederick Vol#: 210

C 3218 Jon Gardner Vol#: 210

C 3219 Chad Michel Vol#: 210

C 3220 Mellisa Calocerinos Vol#: 210

C 3221 Cynthia A. Archaney, MD Vol#: 210

C 3222 Dianne Ensign Vol#: 210

C 3223 Mary Esther Fritz Vol#: 210

C 3224 Nora Schumacher Vol#: 210

C 3225 M.E. Smitham Vol#: 210

C 3226 Charlotte Cimino Vol#: 210

C 3227 J. Capazzelli Vol#: 210

C 3228 Susan Williams Vol#: 210

C 3229 Sherry Ochoa-Rounkles Vol#: 210

C 3230 Elsie L. Stebbings Vol#: 210

C 3231 Lester Schlosberg Vol#: 210

C 3232 Carol Krohn Vol#: 210

C 3233 Peter Wernick Vol#: 210

C 3234 Law Offices of David H. Zoberg Vol#: 210

C 3235 Susan Johnson Vol#: 210

C 3236 Gregory Bungo Vol#: 210

C 3237 Anne Miller Vol#: 210

C 3238 Ann Blossom Vol#: 210

C 3239 Ann DeLollis Vol#: 210

C 3240 Carmita Frost Vol#: 210

C 3241 Michael Brenner Vol#: 210

C 3242 Frances Krohn Vol#: 210

C 3243 Frances Segal Vol#: 210

C 3244 Bernadette Latin Vol#: 210

C 3245 Winifred J. Dushkind Vol#: 210

C 3246 Emil J. Walcer Vol#: 210

C 3247 Abraham Koslof Vol#: 210

C 3248 Ruth Osias Vol#: 210

C 3249 Bea Koslof Vol#: 210

C 3250 Tatyana Rursell Vol#: 210

C 3251 Vivian Sontag Vol#: 210

C 3252 M.E. Mitchell Vol#: 210

C 3253 Lorraine Beotman Vol#: 210

C 3254 Terri Leventer Vol#: 210

00D-1296 Importation of Pasteurized Milk Ordinance (PMO)

C 1 South Mountain Creamery Vol#: 1

00D-1393 Screening tests labeled for use w/ Cadaveric blood Specimens

C 7 CORE Center for Organ Recovery & Educati Vol#: 1

00D-1562 Clinical Data In Marketing Applications

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 53 Honorable Fred Thompson (CI) Vol#: 78

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9042 Vernon McMillion Vol#: 332

C 9043 Mary E. Mccormick Vol#: 332

C 9044 Catherine M. Hunt Vol#: 332

C 9045 Kathleen Hanrahan Vol#: 332

C 9046 Nicole James Vol#: 332

C 9047 David McLean Vol#: 332

C 9048 Freddie Hart Vol#: 332

C 9049 Lessica Stellar Vol#: 332

C 9050 Lessica Stellar Vol#: 332

C 9051 Elmer Coffelt Vol#: 332

C 9052 David Yoder Vol#: 332

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

BKG 2 BACKGROUND Vol#: 13

NEC 1 Vol#: 13

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

BKG 2 BACKGROUND Vol#: 16

NEC 1 Vol#: 16

00P-1510 Establish safety of Echinacea extract as a GRAS pharmaceutic

LET 2 HFD-7 to Pharmaceutical Consulting Vol#: 4

01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled

C 8 Grace Livermore Vol#: 1

01D-0281 Proposed Globally Harmonized Alternative for PMA Procedures

C 5 American Dental Assn Vol#: 1

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

C 3 American Dental Assn Vol#: 1

01M-0329 Corometrics Model 120 F-Series Maternal/Fetal Oxygen Saturiz

AAV 1 GE Medical Systems Information Technolog Vol#: 1

CR 1 GE Medical Systems Information Technolog Vol#: 1

01N-0048 CGMP Regulations for Type A Medicated Articles

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

01N-0176 GLP Regulations for Nonclinical Laboratory Studies

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

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

EC 195 Mr. David Macon Vol#: 4

01N-0277 Reports of Corrections and Removals

N 2 Vol#: 1

01N-0402 Third-Party Submissions review/quality system inspections

N 1 Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 335 Carol Slechta Vol#: 18

EMC 336 Diana Carlin Vol#: 18

EMC 337 Cedric de La Beaujardiere Vol#: 18

EMC 338 Laurie Keith Vol#: 18

EMC 339 Mara Wile Vol#: 18

EMC 340 Priscilla Mattison Vol#: 18

EMC 341 Patricia Kramer Vol#: 18

EMC 342 Larry Bohs Vol#: 18

EMC 343 Chrystal Jaeger Vol#: 18

EMC 344 Daniel Moore Vol#: 18

EMC 345 Mary Mackenzie, BFA Vol#: 18

EMC 346 Sharon Krawczyk Vol#: 18

EMC 347 Marcus Lanskey Vol#: 18

EMC 348 Adam Polakoff Vol#: 18

EMC 349 Kathleen Hogue Vol#: 18

EMC 350 Marcie LaBelle Vol#: 18

EMC 351 John Mellquist Vol#: 18

EMC 352 Phillip Raymond Vol#: 18

EMC 353 Lisa Poser Vol#: 18

EMC 354 number not used Vol#: 18

EMC 355 Robert & Joan Holt Vol#: 18

EMC 356 Thomas Kroupa Vol#: 18

EMC 357 Edward Ramsey Vol#: 18

EMC 358 Mary Lynn Russo Vol#: 18

EMC 359 Brenda Beall Vol#: 18

EMC 360 Jeff Bennett Vol#: 18

EMC 361 Michael Piehl Vol#: 18

EMC 362 Laurie Forti Vol#: 18

EMC 363 Lorinda Langner Vol#: 18

EMC 364 Pat Bily Vol#: 18

EMC 365 Harold Day Vol#: 18

EMC 366 Barb Sashaw Vol#: 18

EMC 367 John Todd Vol#: 18

EMC 368 Marilyn Pierson Vol#: 18

EMC 369 Ian Gillespie Vol#: 18

EMC 370 Joan Mazurek Vol#: 18

EMC 371 Jon Thompson Vol#: 18

EMC 372 Tory Thompson Vol#: 18

EMC 373 number not used Vol#: 18

EMC 374 Jerry Mazurek Vol#: 18

EMC 375 number not used Vol#: 18

EMC 376 Barbara Macdonald Vol#: 18

EMC 377 Cynthia Anderson Vol#: 18

EMC 378 Susan Milliner Vol#: 18

EMC 379 Denny Waxman Vol#: 18

EMC 380 number not used Vol#: 18

EMC 381 Paul Platt Vol#: 18

EMC 382 Judy Spencer Vol#: 18

EMC 383 Rene Hanna Vol#: 18

EMC 384 Clyde Everton Vol#: 18

EMC 385 Christine Farlow Vol#: 18

EMC 386 Elliot Feldman Vol#: 18

EMC 387 David Busby Vol#: 18

EMC 388 Harold Samuels Vol#: 18

EMC 389 Cathy Holt Vol#: 18

EMC 390 Lisa Maahs Vol#: 18

EMC 391 Jose Perez Vol#: 18

EMC 392 Roland Vollmann Vol#: 18

EMC 393 Diane Kirkland Vol#: 18

EMC 394 Allison Mannos Vol#: 18

EMC 395 Barbara Docs Vol#: 18

EMC 396 Robert E. Reynolds Vol#: 18

EMC 397 Laura Lasala Vol#: 18

EMC 398 Anita Siegel Vol#: 18

EMC 399 Jim Uleman Vol#: 18

EMC 400 Ruth Mannich Vol#: 18

EMC 401 Marlin Dixon Vol#: 18

EMC 402 Ann Kratzer Vol#: 18

EMC 403 Susan Shankle Vol#: 18

EMC 404 Ron Chacey Vol#: 18

EMC 405 Mimi Maloney Vol#: 18

EMC 406 William Bracken Vol#: 18

EMC 407 Dee Mancini Vol#: 18

EMC 408 Amie Coomer Vol#: 18

EMC 409 Jessica Sweeney Vol#: 18

EMC 410 Dr. and Mrs. Ronald Forthofer Vol#: 18

EMC 411 Daniel Read Vol#: 18

EMC 412 Maureen Roach Vol#: 18

EMC 413 Dorothy Nelson Vol#: 18

EMC 414 Kathleen Clark Vol#: 18

EMC 415 Lorrie Forster Vol#: 18

EMC 416 Marina McCoy Vol#: 18

EMC 417 Anna Clarke Vol#: 18

EMC 418 Dona Heiner Vol#: 18

EMC 419 Virginia Oram, ND Vol#: 18

EMC 420 Claire Perricelli Vol#: 18

EMC 421 Helen Kintner Vol#: 18

EMC 422 Ethelrose Patrick Vol#: 18

EMC 423 Rebecca Tolin Vol#: 18

EMC 424 Patricia Kessler Vol#: 18

EMC 425 Brad Kindelberger Vol#: 18

EMC 426 Kari Pond Vol#: 18

EMC 427 Gloria Bristol Vol#: 18

EMC 428 Elizabeth von Dreele Vol#: 18

EMC 429 Lisa Lynott Vol#: 18

EMC 430 Gregory Pais Vol#: 18

EMC 431 Mike Weinberg Vol#: 18

EMC 432 Elizabeth Finch Vol#: 18

EMC 433 Danielle Hastings Vol#: 18

EMC 434 Willis Richardson Vol#: 18

EMC 435 Susan Osborne Vol#: 18

EMC 436 Jason J. Green Vol#: 18

EMC 437 Michael Ober Vol#: 18

EMC 438 A. Quartermain Vol#: 18

EMC 439 Pandora Rose Vol#: 18

EMC 440 Richard & Dorothy Chamberlin Vol#: 18

EMC 441 Eva Pizarro Vol#: 18

EMC 442 Renata Januszewski Vol#: 18

EMC 443 Barbara Fava Vol#: 18

EMC 444 Adele Kushner Vol#: 18

EMC 445 Connie Tsouras Vol#: 18

EMC 446 Beth S. Long Vol#: 18

EMC 447 Janet Lant Vol#: 18

EMC 448 Walter Grant Vol#: 18

EMC 449 Tom Shoemaker Vol#: 18

EMC 450 Carole Good Vol#: 18

EMC 451 Jane Miller Vol#: 18

EMC 452 Paul Trepes Vol#: 18

EMC 453 Karin Antal Vol#: 18

EMC 454 number not used Vol#: 18

EMC 455 Cori Saraf Vol#: 18

EMC 456 Bob Dozor Vol#: 18

EMC 457 Phyllis Greenberg Vol#: 18

EMC 458 Roger Ferguson Vol#: 18

EMC 459 Rebecca Lieberg Vol#: 18

EMC 460 Kathleen Clemmons Vol#: 18

EMC 461 Erika Testerman Vol#: 18

EMC 462 Paul Woolery Vol#: 18

EMC 463 Colleen Turrell Vol#: 18

EMC 464 Marguerite Bunyan Vol#: 18

EMC 465 number not used Vol#: 18

EMC 466 Lynette Horner Vol#: 18

EMC 467 Jill Ayn Schneider Vol#: 18

EMC 468 Anne Story Vol#: 18

EMC 469 Gail Harmon Vol#: 18

EMC 470 Herbert Shaw Vol#: 18

EMC 471 Deana Smiel Vol#: 18

EMC 472 Jorg Winterer Vol#: 18

EMC 473 Helene Maidan Vol#: 18

EMC 474 David Freyer Vol#: 18

EMC 475 Deborah Klein Vol#: 18

EMC 476 Debra King Vol#: 18

EMC 477 Brian Lutenegger Vol#: 18

EMC 478 Mr. and Mrs. D.A. Ryan Vol#: 18

EMC 479 Gustin Prudner Vol#: 18

EMC 480 Margaret Leonard Vol#: 18

EMC 481 Martha Hawks Vol#: 18

EMC 482 Ruth Gabey Vol#: 18

EMC 483 Heather Roberts Vol#: 18

EMC 484 Matthew Kendz Vol#: 18

EMC 485 Paul A. Kotta Vol#: 18

EMC 486 Carol Moore Vol#: 18

EMC 487 Mike Betz Vol#: 18

EMC 488 Nori J. Muster Vol#: 18

EMC 489 Jamie Ackley Vol#: 18

EMC 490 Reeta Roo Vol#: 18

EMC 491 David A. Bove, ND Vol#: 18

EMC 492 Jennifer & Mitchell Frieder Vol#: 18

EMC 493 Jeffrey Garcia Vol#: 18

EMC 494 Susanne Griffin Vol#: 18

EMC 495 number not used Vol#: 18

EMC 496 Joseph and Marilyn Gibbons Vol#: 18

EMC 497 Carol Lownes Vol#: 18

EMC 498 Anita Beckwith Vol#: 18

EMC 499 Ola Flodin Vol#: 18

EMC 500 Zemach Wilson Vol#: 18

EMC 501 Bernita Czerpak Vol#: 30

EMC 502 Dianne Burnham Vol#: 30

EMC 503 Gloria Nissenson Vol#: 30

EMC 504 Maida Genser Vol#: 30

EMC 505 Penelope Gedeon Vol#: 30

EMC 506 Christopher Dare Vol#: 30

EMC 507 Susannah Frishman-Phillips Vol#: 30

EMC 508 Edwin Pratt, Jr. Vol#: 30

EMC 509 Floyd Westervelt Vol#: 30

EMC 510 Elsa Turnbull Vol#: 30

EMC 511 Faye Jones Vol#: 30

EMC 512 Kathy McClure Vol#: 30

EMC 513 Melissa Morris Vol#: 30

EMC 514 Christine Burke Vol#: 30

EMC 515 Heather Spencer Vol#: 30

EMC 516 Gabrielle Kayser Vol#: 30

EMC 517 Eileen McNamara Vol#: 30

EMC 518 Kim Pereira Vol#: 30

EMC 519 Cynthia Olsen Vol#: 30

EMC 520 Leni Fried Vol#: 30

EMC 521 Andrew Tegethoff Vol#: 30

EMC 522 Richard & Roberta Baldwin Vol#: 30

EMC 523 Jonathan Cook Vol#: 30

EMC 524 Vivienne Sturgill Vol#: 30

EMC 525 Brent Carter Vol#: 30

EMC 526 Joan Newman Vol#: 30

EMC 527 Timothy O'Donnell Vol#: 30

EMC 528 Pamela Poindexter Vol#: 30

EMC 529 Dr and Mrs Gerson Lesser Vol#: 30

EMC 530 Patrick Wilson-Welsh Vol#: 30

EMC 531 Isi Tukuafu Vol#: 30

EMC 532 Ken and Val Hansen Vol#: 30

EMC 533 Harry Hettinger Vol#: 30

EMC 534 Wilma Hettinger Vol#: 30

EMC 535 Marsha Hansen Vol#: 30

EMC 536 Ronald Hansen Vol#: 30

EMC 537 Chistopher Hansen Vol#: 30

EMC 538 Donna Mickleson Vol#: 30

EMC 539 Dianna Morris Vol#: 30

EMC 540 Amy M. Chernoff-Itescu Vol#: 30

EMC 541 Clifford S. Garner, PhD Vol#: 30

EMC 542 Jennifer Goff Vol#: 30

EMC 543 Jeanne C. Jackson Vol#: 30

EMC 544 Cheryl Hawkes Vol#: 30

EMC 545 Sat Ganesha Khalsa Vol#: 30

EMC 546 Lydia Koroluk Vol#: 30

EMC 547 Joyce Battistone Vol#: 30

EMC 548 Sharon Cunningham Vol#: 30

EMC 549 Heather A. Hansen Vol#: 30

EMC 550 Chris Striegel Vol#: 30

EMC 551 Julia Borg Vol#: 30

EMC 552 James F. York Vol#: 30

EMC 553 Larry Paulsen Vol#: 30

EMC 554 Thomas Connor Vol#: 30

EMC 555 Brent Barnes Vol#: 30

EMC 556 Linda Moorcock Vol#: 30

EMC 557 Cheryl H. Williams Vol#: 30

EMC 558 Katie Christian Vol#: 30

EMC 559 Corrie Navis Vol#: 30

EMC 560 Kezia Tenenbaum Vol#: 30

EMC 561 Peter R. Root Vol#: 30

EMC 562 Marie Tufts Vol#: 30

EMC 563 Tonya Jansen Vol#: 30

EMC 564 Hillary Bird Vol#: 30

EMC 565 Laura Wilensky Vol#: 30

EMC 566 Barbara Gates Vol#: 30

EMC 567 Shirley Vincent Vol#: 30

EMC 568 Kimberlee Russell Vol#: 30

EMC 569 Ann Blatnik Vol#: 30

EMC 570 Maribel Todd Vol#: 30

EMC 571 Karen Anderson Vol#: 30

EMC 572 Diane Valletta Vol#: 30

EMC 573 Siobhan Keleher Vol#: 30

EMC 574 Lane Utley Vol#: 30

EMC 575 Gregory Wing Vol#: 30

EMC 576 Rex Helfant Vol#: 30

EMC 577 Frank Pettinger Vol#: 30

EMC 578 Dariah Morgan Vol#: 30

EMC 579 Dusty Hiles Vol#: 30

EMC 580 John Grill Vol#: 30

EMC 581 Neva Glenn Vol#: 30

EMC 582 Anne Contratto Vol#: 30

EMC 583 Marie Enright Vol#: 30

EMC 584 Scott Diehl Vol#: 30

EMC 585 Steve Shapiro Vol#: 30

EMC 586 Sheryl Uson Vol#: 30

EMC 587 Jennifer Storey Vol#: 30

EMC 588 Jacqualine Manoppo Vol#: 30

EMC 589 Jonothan Polly Vol#: 30

EMC 590 Sharon Jackson Vol#: 30

EMC 591 Barry K. Miller Vol#: 30

EMC 592 Sue Blocki-McKenna Vol#: 30

EMC 593 Linda Ruhnke Vol#: 30

EMC 594 Sherry Albarado Vol#: 30

EMC 595 Liza Sheehan Vol#: 30

EMC 596 David Medvigy Vol#: 30

EMC 597 Ed Gutierrez Vol#: 30

EMC 598 Barbara Kurtz Vol#: 30

EMC 599 Leitha Haffer Vol#: 30

EMC 600 Richard Luna Vol#: 30