Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on September 25, 2002

TABLE OF CONTENTS

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86F-0208 MYCO-PROTEIN DERIVED FROM FUSARIUM GRANINEARUM SOURCE PRO 
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa 
00D-1598 Voluntary Labeling for Bioengineered Foods 
00N-1200 Dietary Supplements Containing Ephedrine Alkaloids 
00N-1663 Investigational New Drugs: Export Requirements 
01D-0064 Encapsulated Amalgam,Amalgam Alloy & Dental Mercury Labeling *
01N-0067 Reclassification of Dental Mercury 
02D-0350 Handling and Retention of Bioavailability and Bioequivalence
02N-0276 Bioterrorism Preparedness;Registration of Food Facilities
02P-0317 Recall Aspartame as a Neurotoxic Drug 

76N-052N OTC Nasal Decongestants

EMC 129 Diane Hitt Vol#: 77

78N-0064 OTC Antiperspirant

ACK 3 HFA-305 Vol#: 16

86F-0208 MYCO-PROTEIN DERIVED FROM FUSARIUM GRANINEARUM SOURCE PRO

EMC 8 Number not used. Vol#: 1

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

EAPE37 Center for Science in the Public Interes Vol#: 4

EAPE38 M&R Strategic Services Vol#: 4

EAPE39 National Pork Producers Council Vol#: 4

EAPE40 National Pork Producers Council Vol#: 4

EAPE41 the HSUS Vol#: 4

EAPE42 Laboratory for Foodborne Zoonoses, Healt Vol#: 4

EAPE43 CVM Vol#: 4

EAPE44 Intralytix, Inc. Vol#: 4

EAPE45 FDA/CVM Vol#: 4

EAPE46 Environmental Defense Vol#: 4

EAPE47 FDA-CVM Vol#: 4

EAPE48 FDA/CVM Vol#: 4

EAPE49 FDA Vol#: 4

EAPE50 CVM/OM Vol#: 4

EAPE51 FDA/CVM/OD Vol#: 4

EAPE52 FDA Center for Veterinary Medicine Vol#: 4

EAPE53 Environmental Defense Vol#: 4

EAPE54 Private Vol#: 4

EAPE55 Elanco Animal Health Vol#: 4

EAPE56 FDA/CVM Vol#: 4

EAPE57 Union of Concerned Scientists Vol#: 4

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

C 68 Joy Reese Vol#: 4

EMC 353 Donnella Fradkin Vol#: 5

EMC 354 Scott Johnson Vol#: 5

EMC 355 Andrew Hwang Vol#: 5

EMC 356 Jennifer O'Brien Vol#: 5

EMC 357 Jennifer O'Brien Vol#: 5

EMC 358 Angela Coccoluto Vol#: 5

EMC 359 Angela Coccoluto Vol#: 5

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

C 66 Joy Reese Vol#: 4

EMC 256 Donnella Fradkin Vol#: 5

EMC 257 Scott Johnson Vol#: 5

EMC 258 Andrew Hwang Vol#: 5

EMC 259 Jennifer O'Brien Vol#: 5

EMC 260 Jennifer O'Brien Vol#: 5

EMC 261 Angela Coccoluto Vol#: 5

EMC 262 Belinda Lee Vol#: 5

EMC 263 Sharon E. Ciri Vol#: 5

EMC 264 J. Roberts Vol#: 5

EMC 265 Eric Jaimes Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

C 66 Joy Reese Vol#: 3

EMC 255 Donnella Fradkin Vol#: 4

EMC 256 Scott Johnson Vol#: 4

EMC 257 Andrew Hwang Vol#: 4

EMC 258 Jennifer O'Brien Vol#: 4

EMC 259 Jennifer O'Brien Vol#: 4

EMC 260 Angela Coccoluto Vol#: 4

EMC 261 Belinda Lee Vol#: 4

EMC 262 Sharon E. Ciri Vol#: 4

EMC 263 J. Roberts Vol#: 4

EMC 264 Eric Jaimes Vol#: 4

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

C 67 Joy Reese Vol#: 3

EMC 258 Donnella Fradkin Vol#: 4

EMC 259 Scott Johnson Vol#: 4

EMC 260 Andrew Hwang Vol#: 4

EMC 261 Jennifer O'Brien Vol#: 4

EMC 262 Jennifer O'Brien Vol#: 4

EMC 263 Angela Coccoluto Vol#: 4

EMC 264 Belinda Lee Vol#: 4

EMC 265 Sharon E. Ciri Vol#: 4

EMC 266 J. Roberts Vol#: 4

EMC 267 Eric Jaimes Vol#: 4

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3718 Jeremy Scott Vol#: 512

EMC 3719 Megan Livingston Vol#: 512

EMC 3720 Barbara Labrecque Vol#: 512

EMC 3721 Silvia Ceravolo Vol#: 512

EMC 3722 Marilyn Chatmon Vol#: 512

EMC 3723 Delores Dean Vol#: 512

EMC 3724 Scott Johnson Vol#: 512

EMC 3725 Jennifer Stolarz Vol#: 512

EMC 3726 Andrew Hwang Vol#: 512

EMC 3727 Bret Walburg Vol#: 512

EMC 3728 Jennifer O'Brien Vol#: 512

EMC 3729 Richard Fortner Vol#: 512

EMC 3730 Sharon E. Ciri Vol#: 512

EMC 3731 J. Roberts Vol#: 512

EMC 3732 Donald Leonhardt Vol#: 512

EMC 3733 Timothy Ringgold Vol#: 512

EMC 3734 Eric Jaimes Vol#: 512

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 886 Kelly Devane Vol#: 212

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 399 Rita Rammell Vol#: 21

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9832 HFS-822 to Vircher B. Floyd Vol#: 572

00N-0598 Dietary Supplement Health Claim/Implementation of Pearson De

EMC 32 Cindy Mockel Vol#: 7

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

EMC 38 Assn of Food and Drug Officials Vol#: 78

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9400 Vircher B. Floyd Vol#: 408

00N-1663 Investigational New Drugs: Export Requirements

EMC 2 Beacons Clinical Research Counsultants Vol#: 1

EMC 3 Eli Lilly and Company Vol#: 1

EMC 4 Pharmacia Vol#: 1

01D-0064 Encapsulated Amalgam,Amalgam Alloy & Dental Mercury Labeling

EMC 3 Consumers for Dental Choice, Inc. Vol#: 1

EMC 4 Consumers for Dental Choice, Inc. Vol#: 1

EMC 5 Anne O. Summers, PhD Vol#: 1

EMC 6 Sandy Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

C 65 Joy Reese Vol#: 5

EMC 355 Donnella Fradkin Vol#: 6

EMC 356 Scott Johnson Vol#: 6

EMC 357 Andrew Hwang Vol#: 6

EMC 358 Jennifer O'Brien Vol#: 6

EMC 359 Jennifer O'Brien Vol#: 6

EMC 360 Angela Coccoluto Vol#: 6

EMC 361 Belinda Lee Vol#: 6

EMC 362 Sharon E. Ciri Vol#: 6

EMC 363 J. Roberts Vol#: 6

EMC 364 Eric Jaimes Vol#: 6

01N-0067 Reclassification of Dental Mercury

EMC 534 Tara Brown Vol#: 10

EMC 535 Lauranell Scarfo Vol#: 10

EMC 536 Craig Gilgallon, Esq Vol#: 10

EMC 537 Tara Brown Vol#: 10

EMC 538 Cindy Campbell Vol#: 10

EMC 539 Mary Ann Newell Vol#: 10

EMC 540 Dr. Ralph Wilson Vol#: 10

EMC 541 Tom Campbell Vol#: 10

EMC 542 Boyd E. Haley, PhD Vol#: 10

EMC 543 Boyd E. Haley, PhD Vol#: 10

EMC 544 Elise Craig Vol#: 10

EMC 545 Dr. James Medlock Vol#: 10

EMC 546 Teresa Badillo Vol#: 10

EMC 547 Ed Hogan Vol#: 10

EMC 548 Mary Ann Newell Vol#: 10

EMC 549 Mary Ann Newell Vol#: 10

EMC 550 Bette Moksnes-Koski Vol#: 10

EMC 551 Michael H. Michaud Vol#: 10

EMC 552 Boris Dragin Vol#: 10

EMC 553 Joann C. Price Vol#: 10

EMC 554 Kathleen Kelly Vol#: 10

EMC 555 Marlene Lorczakowski Adams, BS Chemistry Vol#: 10

EMC 556 Freya B. Koss Vol#: 10

EMC 557 Dr. Steven A. Swindler, DDS Vol#: 10

EMC 558 Hal A. Huggins, DDS, MS Vol#: 10

EMC 559 Consumers for Dental Choice, Inc. Vol#: 10

EMC 560 Consumers for Dental Choice, Inc. Vol#: 10

EMC 561 Mary Ann Newell Vol#: 10

EMC 562 David S. Lawrence Vol#: 10

EMC 563 Debbie Pettigrew Vol#: 10

EMC 564 Linda Paolicchi Vol#: 10

EMC 565 Dr. Mary Battilocchi, N.D. Vol#: 10

EMC 566 Fran E. Oyler Vol#: 10

EMC 567 Lucille Balukjian Vol#: 10

EMC 568 Mark A. Breiner, DDS Vol#: 10

EMC 569 Jeffrey A. Nelson Vol#: 10

EMC 570 Cindy Campbell Vol#: 10

EMC 571 Wanda Brown Vol#: 10

EMC 572 Thomas Bertka Vol#: 10

EMC 573 Jim Gruber Vol#: 10

EMC 574 State Representative Hal Lynde Vol#: 10

EMC 575 Mary Ann Newell Vol#: 10

EMC 576 Susan Booher Vol#: 10

EMC 577 Rene Ekas Vol#: 10

EMC 578 Merrilee Petinger Vol#: 10

EMC 579 Merrilee Petinger Vol#: 10

EMC 580 Pedro Tibau Vol#: 10

EMC 581 Thomas Bertka Vol#: 10

EMC 582 Mary Ann Newell Vol#: 10

EMC 583 Marie Larson Vol#: 10

EMC 584 Bev Hatzenbeler Vol#: 10

EMC 585 David S. Banks, DDS Vol#: 10

EMC 586 Maurice A. Davis Vol#: 10

EMC 587 Patty Beck Vol#: 10

EMC 588 David S. Banks, DDS Vol#: 10

EMC 589 Dick Newell Vol#: 10

EMC 590 Tim McCoy Vol#: 10

EMC 591 Mary Ann Newell Vol#: 10

EMC 592 No signature Vol#: 10

EMC 593 Mary Ann Newell Vol#: 10

EMC 594 Mary Ann Newell Vol#: 10

EMC 595 Mary Ann Newell Vol#: 10

EMC 596 Tammy L. Slater-McCoy Vol#: 10

EMC 597 Philip Gerard Dahl, DDS Vol#: 10

EMC 598 Dr. Jonathan J. Bromboz, DDS Vol#: 10

EMC 599 Elizabeth Hopp Vol#: 10

EMC 600 No signature Vol#: 10

EMC 601 Jon R. Mundall, M.D. Vol#: 10

EMC 602 California State Legislature Vol#: 10

EMC 603 Deborah L. Pence, DDS Vol#: 10

EMC 604 Ken & Shalini Van Skaik Vol#: 10

EMC 605 Mary Ann Newell Vol#: 10

EMC 606 Justin Nutzman Vol#: 10

EMC 607 Birgitta Gustafson Vol#: 10

EMC 608 Birgitta Gustafson Vol#: 10

EMC 609 Sandy Vol#: 10

EMC 610 Alan M. Dattner, MD Vol#: 10

EMC 611 Marianne Finnie Vol#: 10

EMC 612 Rosie Vol#: 10

EMC 613 Sue Bailey Vol#: 10

EMC 614 Barbara Rider Vol#: 10

EMC 615 Jeanne K. Bailey Vol#: 10

EMC 616 Bernard Windham Vol#: 10

EMC 617 Don Reif Vol#: 10

EMC 618 Freya B. Koss Vol#: 10

EMC 619 Myrba Cruz Vol#: 10

EMC 620 James Page Vol#: 10

EMC 621 Sara Moore-Hines Vol#: 10

01P-0120 Ban Unsafe IV Catheters and other Devices

EMC 3 Doris Gregory Vol#: 1

EMC 4 AFSCME Vol#: 1

EMC 5 Medisystems Corporation Vol#: 1

EMC 6 AdvaMed Vol#: 1

EMC 7 AFSCME Vol#: 1

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1120 Carin Lovell Vol#: 5

EMC 1121 Sue Haglan Vol#: 5

EMC 1122 Helene and Peter Longden Vol#: 5

01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II

EMC 378 Meryl Nass, MD Vol#: 4

02D-0350 Handling and Retention of Bioavailability and Bioequivalence

C 6 Abbott Laboratories, Inc. Vol#: 1

EMC 1 PRA International Vol#: 1

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

EC 31 Southern Pride Catfish Vol#: 3

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 16 Mission Possible Vol#: 1

EMC 17 Mission Possible Vol#: 1

EMC 18 Mission Possible Vol#: 1

EMC 19 Rich Murray Vol#: 1

EMC 20 Rich Murray Vol#: 1