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DOCKETS ENTERED on 11/27/02

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants *
98D-1146 Microbial effects of antimicrobial new animal drugs/human sa *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1539 Electronic Records & Signatures, Retention of Electronic Rec *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
01P-0572 Petition for Regulation of Ariva Tobacco Lozenges *
02D-0320 Hold following clinical investigator misconduct *
02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control *
02N-0273 Animal Proteins Prohibited in Ruminant Feed *
02N-0359 Ingrown Toenail Relief drug products OTC human use *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02N-0456 Determine Hosp. Proc. for Opened-But-Unused, Single Use Devi *
02N-0466 Safety, Clinical and Immune Response of Dryvax *
02P-0075 Flavored Candy-like Products Containing Tobacco *
02P-0469 ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2% *
02P-0499 ANDA Suitability for Metformin Hydrochloride Tablets Oral So *

76N-052N OTC Nasal Decongestants

LET 121 HFD-1 to Bayer Corporation Vol#: 77

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

EC 15 Ms. Gayle Dietz Vol#: 65

95N-0308 Inapplicability of the Dietary Supplement Health & Ed. Act t

EMC 80 Gary Vail Vol#: 2

EMC 81 Leeanne M. Schultz Vol#: 2

EMC 82 Candace M. Hoke Vol#: 2

EMC 83 Kevin Edwards Vol#: 2

EMC 84 Laurell L. Tyler Vol#: 2

EMC 85 Lucy Bernstein Vol#: 2

EMC 86 Eleanor Kellon, V.M.D. Vol#: 2

EMC 87 Joan L. Nagy Vol#: 2

EMC 88 Joan M. Benner Vol#: 2

EMC 89 Randy Tuomisto Vol#: 2

EMC 90 jacqui303 Vol#: 2

EMC 91 Jon Zandi Vol#: 2

EMC 92 Debra Tibbitts, DVM Vol#: 2

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

C 68 Iowa State University Vol#: 2

C 69 Humane Society of the United States Vol#: 2

C 70 Honorable Edward M. Kennedy (CI) Vol#: 2

C 71 Infectious Diseases Society of America Vol#: 2

C 72 Elanco Aminal Health Vol#: 2

C 73 American Veterinary Medical Assn Vol#: 2

C 74 National Pork Board Vol#: 2

C 75 Phibro Animal Health Vol#: 2

EC 3 Sierra Club Vol#: 2

EC 4 Nebraska Pork Producers Association Vol#: 2

EC 5 American Veterinary Medical Association Vol#: 2

EC 6 Environmental Defense Vol#: 2

EC 7 Pfizer Inc, Animal Health Group Vol#: 2

EC 8 National Pork Board Vol#: 2

EC 9 Oklahoma Pork Council Vol#: 2

EC 10 American Association of Swine Veterinari Vol#: 2

EC 11 American College of Poultry Veterinarian Vol#: 2

EMC 564 Samantha Tessier Vol#: 15

EMC 565 Carmen Pomales Vol#: 15

EMC 566 Katie Hamman Vol#: 15

EMC 567 Jay Howlow Vol#: 15

EMC 568 Anne Beckmann Vol#: 15

EMC 569 Rev Ralph John Monteiro, OSA Vol#: 15

EMC 570 Barry Sapp Vol#: 15

EMC 571 Molly Helt Vol#: 15

EMC 572 Cherie Earl Vol#: 15

EMC 573 Rosella Bear Vol#: 15

EMC 574 Dee Scarr Vol#: 15

EMC 575 Drew Koslow Vol#: 15

EMC 576 Ann Bauman Vol#: 15

EMC 577 Amanda Hayes Vol#: 15

EMC 578 George L. Trigg Vol#: 15

EMC 579 Mary Lou Sharp Vol#: 15

EMC 580 Karen Vitulano Vol#: 15

EMC 581 Ann Calhoun Vol#: 15

EMC 582 Shannon Bigner Vol#: 15

EMC 583 Kelly Michelle Vol#: 15

EMC 584 Vivienne Sturgill Vol#: 15

EMC 585 Jennifer Ross Vol#: 15

EMC 586 Matt Mangione Vol#: 15

EMC 587 Teri Hopkins Vol#: 15

EMC 588 Paul Jacobson Vol#: 15

EMC 589 Karen Fields, PhD Vol#: 15

EMC 590 Armando Corbelle Vol#: 15

EMC 591 Lisa Cass Vol#: 15

EMC 592 Liza Davis Vol#: 15

EMC 593 Janice Wolff Vol#: 15

EMC 594 Amanda Young Vol#: 15

EMC 595 Janet Unger Vol#: 15

EMC 596 Ashley Gronek Vol#: 15

EMC 597 Rachel Dowell Vol#: 15

EMC 598 Elizabeth Palmer Vol#: 15

EMC 599 Roberta S. Beem Vol#: 15

EMC 600 Elisa Villemaire Vol#: 15

EMC 601 Harriet Hacker Vol#: 15

EMC 602 Karen Pearlman Vol#: 15

EMC 603 Scott Wachenheim Vol#: 15

EMC 604 Mike Strawn Vol#: 15

EMC 605 Sarah Miller Vol#: 15

EMC 606 John Ho Vol#: 15

EMC 607 Patricia Garcia Vol#: 15

EMC 608 Kellie Geldreich Vol#: 15

EMC 609 Douglas Pressel Vol#: 15

EMC 610 Jerry Amos Vol#: 15

EMC 611 Lorie Morgan Vol#: 15

EMC 612 Judy Reed Vol#: 15

EMC 613 Georgiana Lewis Anderson Vol#: 15

EMC 614 AnimalVoices Vol#: 15

EMC 615 Cindy Lamberti Vol#: 15

EMC 616 Miranda Glasbergen Vol#: 15

EMC 617 Cheryl Adam Vol#: 15

EMC 618 Kaylan Greenwald Vol#: 15

EMC 619 Corinne Merwarth Vol#: 15

EMC 620 Carrie Savery Vol#: 15

EMC 621 Marilyn Ortt Vol#: 15

EMC 622 Donald F. Bent, PhD Vol#: 15

EMC 623 Frank & Ellen Wentz Vol#: 15

EMC 624 Mary Kay Craig Vol#: 15

EMC 625 Elsa Torres Vol#: 15

EMC 626 Elizabeth Schaefer Vol#: 15

EMC 627 Marlene Gargan Vol#: 15

EMC 628 Cathy Kunkel Vol#: 15

EMC 629 Ilona Lind Vol#: 15

EMC 630 Leslie Figueroa Vol#: 15

EMC 631 CSPI Vol#: 15

EMC 632 Abby Schwartz Vol#: 15

EMC 633 Jennifer Gibbs Vol#: 15

EMC 634 Mark Richards Vol#: 15

EMC 635 National Turkey Federation Vol#: 15

EMC 636 Pia Maria Castegnaro Vol#: 15

EMC 637 Carie Perkins Vol#: 15

EMC 638 Renee P. Snyder, PhD Vol#: 15

EMC 639 Josephine Bellaccomo Vol#: 15

EMC 640 Jacquelyn Hawkins Vol#: 15

EMC 641 Janet Hopkins Vol#: 15

EMC 642 Suzanna Sanborn Vol#: 15

EMC 643 Marie A. Calabrese Vol#: 15

EMC 644 Mark D. Smith Vol#: 15

EMC 645 Eric Piehl Vol#: 15

EMC 646 Shimona Katz Vol#: 15

EMC 647 Michelle Stearns Vol#: 15

EMC 648 Daniel DeSanto Vol#: 15

EMC 649 Michigan Pork Producers Assn Vol#: 15

EMC 650 Animal Health Institute Vol#: 15

EMC 651 Patricia Timm Vol#: 15

EMC 652 Rahat Azfar Vol#: 15

EMC 653 Robert Gibson Vol#: 15

EMC 654 Fern Riley and Family Vol#: 15

EMC 655 Anne Trotter Vol#: 15

EMC 656 Gail Ann Lewis Vol#: 15

EMC 657 Kai Chan Vol#: 15

EMC 658 National Cattlemen's Beef Assn Vol#: 15

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

EMC 2999 Megan Goslee Vol#: 265

EMC 3000 Maisun Jabban-Payne Vol#: 265

EMC 3001 Nancy Shinn Vol#: 265

EMC 3002 Darren & Christie Strain Vol#: 265

EMC 3003 Jennifer Allen Vol#: 265

EMC 3004 Marie Schultz Vol#: 265

EMC 3005 Micron Government Computer Systems, LLC Vol#: 265

EMC 3006 Mrs. Cheryl Kucsera Vol#: 265

EMC 3007 Tiffany Washkewicz Vol#: 265

EMC 3008 Neurotronics, Inc. Vol#: 265

EMC 3009 Sheila Akehurst Vol#: 265

EMC 3010 Erin Bredefeld Vol#: 265

EMC 3011 Katheryn Knorr Vol#: 265

EMC 3012 Luellyn Harris Vol#: 265

EMC 3013 Mr. Ravi Grover Vol#: 265

EMC 3014 Christel Voelske Vol#: 265

EMC 3015 April Diffie Vol#: 265

EMC 3016 Sarah Richards Vol#: 265

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

EMC 314 Jeanne Stancil Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 313 Jeanne Stancil Vol#: 4

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

EMC 316 Jeanne Stancil Vol#: 4

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

EMC 3811 Rob Gould Vol#: 512

EMC 3812 Jeanne Stancil Vol#: 512

EMC 3813 Nicole Cherok Vol#: 512

EMC 3814 Erika Elmore Vol#: 512

EMC 3815 Anna Blurton Vol#: 512

EMC 3816 Pat Bigelow Vol#: 512

EMC 3817 Daniel Shively Vol#: 512

EMC 3818 Judith Barnes Vol#: 512

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

C 2 Bristol-Myers Squibb Vol#: 7

C 3 Baxter Healthcare Corporation Vol#: 7

C 4 National Food Processors Assn (NFPA) Vol#: 7

EMC 6 American Assn of Blood Banks (AABB) Vol#: 7

EMC 7 The Hollis Group, Inc. Vol#: 7

(Part 1) (Part 2)

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

CS 17 HFA-305 Vol#: 329

MO 19 Center for Veterinary Medicine Vol#: 329

OR 18 HF-3 Vol#: 329

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

EMC 1150 Laurence Cain Vol#: 5

01P-0572 Petition for Regulation of Ariva Tobacco Lozenges

SUP 4 GlaxoSmithKline Consumer Healthcare Vol#: 2

02D-0320 Hold following clinical investigator misconduct

EMC 1 Council on Governmental Relations Vol#: 1

02D-0337 Liposome Drug Products:Chemistry, Manufacturing, and Control

EMC 1 Boehringer Ingelheim Pharmaceuticals,Inc Vol#: 1

02N-0273 Animal Proteins Prohibited in Ruminant Feed

EC 3 Dr. Edward McGowan Vol#: 1

EC 4 Number Not Used Vol#: 1

EC 5 Pennsylvania Pork Producers Council Vol#: 1

EMC 2 Edward McGowan Vol#: 1

02N-0359 Ingrown Toenail Relief drug products OTC human use

C 1 Schering-Plough HealthCare Products, Inc Vol#: 1

02N-0445 FDA Regulation of Combination Products; Public Hearing

APE 37 King & Spalding Vol#: 3

LST 3 List of Audio Participants Vol#: 4

TS 1 American Academy of Orthopaedic Surgeons Vol#: 4

TS 2 Oncology Associates of San Diego Vol#: 4

TS 3 Angiogene Inc. Vol#: 4

TS 4 Wyeth Pharmaceuticals, Inc. Vol#: 4

TS 5 Nephros Therapeutics, Inc. Vol#: 4

TS 6 Carnegie Mellon University Vol#: 4

TS 7 NEMA Vol#: 4

TS 8 Medical Imaging Contrast Agent Associati Vol#: 4

TS 9 Hogan & Hartson LLP Vol#: 4

TS 10 Advanced Medical Technology Association Vol#: 4
 
 

TS 11 Aventis Behring Vol#: 4

02N-0456 Determine Hosp. Proc. for Opened-But-Unused, Single Use Devi

C 1 The New York Eye & Ear Infirmary Vol#: 1

C 2 Johnson & Johnson Vol#: 1

C 3 American Hospital Assn. et al Vol#: 1

C 4 AdvaMed, Advanced Medical Technology Ass Vol#: 1

EC 26 Newport Hospital Vol#: 1

EC 27 Healthcare Association of New York State Vol#: 1

02N-0466 Safety, Clinical and Immune Response of Dryvax

C 8 Children's Hospital of Philadelphia Vol#: 1

EC 352 Mrs. Linda Lawson Vol#: 4

EC 353 Mrs. Kheri Tillman Vol#: 4

EC 354 Mrs. Mellissa Keplinger Vol#: 4

EC 355 Ms. Lisa Fairchild Vol#: 4

EC 356 Mr. John Publik Vol#: 4

EC 357 Sprint Vol#: 4

EC 358 Mr. George Mihale Vol#: 4

EC 359 Mrs. Alison Cowen Vol#: 4

EC 360 Ms. Tennille Lisonbee Vol#: 4

EC 361 Private citizen Vol#: 4

EC 362 Mrs. Angela Robinson Vol#: 4

EC 363 Mrs. Jennifer Davies Vol#: 4

EC 364 UT-Houston Medical School Vol#: 4

EC 365 Dr. Gary Erkfritz Vol#: 4

EC 366 Dr. Rhonda Marty-Anderson Vol#: 4

EC 367 Ms. Rivers Quinn Vol#: 4

EC 368 Ms. Susan Bowen Vol#: 4

EC 369 Wyoming Vaccine Information Network Vol#: 4

EC 370 Mrs. gwen murphy Vol#: 4

EC 371 Mrs. Fran Marcyjanik Vol#: 4

EC 372 Mrs. Randi Airola Vol#: 4

EC 373 Ms. PAULETTE WOODS Vol#: 4

EC 374 Family Homeopathy, Inc. Vol#: 4

EC 375 Ms. Cara Weston Vol#: 4

EC 376 Ms. Sandra Van Puymbrouck Vol#: 4

EC 377 Mrs. Michelle McClorey Vol#: 4

EC 378 Mrs. janet eberhardt Vol#: 4

EC 379 Ms. Alicia Hembekides Vol#: 4

EC 380 Mrs. Martina Randall Vol#: 4

EC 381 Mrs. Nancy Gronewold Vol#: 4

EC 382 Mrs. Pam Haley Vol#: 4

EC 383 Ms. Teresa Manidis Vol#: 4

EC 384 Ms. Marguerite Willner Vol#: 4

EC 385 Ms. Beverly Massey Vol#: 4

EC 386 Mrs. Sara Kohn Vol#: 4

EC 387 Mrs. Andrea Fisher Vol#: 4

EC 388 Ms. Kayla Pruett Vol#: 4

EC 389 Kuru Design Vol#: 4

EC 390 Mrs. Stacie Almquist Vol#: 4

EC 391 Ms. Jan Sindelar Vol#: 4

EC 392 Ms. Margaret Haas Vol#: 4

EC 393 Mr. stephen browne Vol#: 3

EC 394 Truman State University Vol#: 3

EC 395 Mrs. Elaine Ruble Vol#: 3

EC 396 Mrs. Shari Graham Vol#: 3

EC 397 Ms. Kelly Anderson Vol#: 3

EC 398 Mrs. Mary Jane Lenhard Vol#: 3

EC 399 Mrs. Carol Olson Vol#: 3

EC 400 Rodger Lenhard Vol#: 3

EC 401 Mrs. Mary Tripp Vol#: 3

EC 402 Lisa Droz'e Vol#: 3

EMC 87 Scott A. Kane Vol#: 1

EMC 88 Deborah Holljes Vol#: 1

EMC 89 Steven Sohnrey Vol#: 1

EMC 90 Linda K. Skiba Vol#: 1

EMC 91 Michael Sterioff Vol#: 1

02P-0075 Flavored Candy-like Products Containing Tobacco

SUP 3 GlaxoSmithKline Consumer Healthcare Vol#: 2

02P-0317 Recall Aspartame as a Neurotoxic Drug

C 1 Donna Fletcher, J.D. Vol#: 1

EMC 64 Tim & Brenda Mulder Vol#: 1

EMC 65 Kaija Paddock Vol#: 1

EMC 66 Ann Cain Vol#: 1

EMC 67 Susan Stewart Vol#: 1

02P-0469 ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2%

ACK 2 HFA-305 Vol#: 1

C 1 Alcon Laboratories Vol#: 1

CR 1 HFA-305 to Alcon Laboratories Vol#: 1

02P-0499 ANDA Suitability for Metformin Hydrochloride Tablets Oral So

ACK 1 HFA-305 Vol#: 1

CP 1 The Weinberg Group Inc. Vol#: 1