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DOCKETS ENTERED on 4/14/03

Docket Number - Title

84B-0181 Blood Grouping Sera Evaluation

RM 1 Recommended Methods Vol#: 1

RM 2 Recommended Methods Vol#: 1

84B-0182 Recommended Methods for Anti-Human Globulin Evaluation

RM 1 Recommended Methods Vol#: 1

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

LET 9 HFS-800 to Emord & Associates P C Vol#: 46

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

C 3990 Weider Nutrition International, Inc. Vol#: 347

C 3991 US Small Business Administration Vol#: 347

C 3992 California Dept of Health Services Vol#: 347

C 3993 American Botanical Council (ABC) Vol#: 347

C 3994 Ashraf Mozayani, PharmD., PhD., D-ABFT Vol#: 347

EMC 472 Ephedra Education Council Vol#: 346

EMC 473 Steven Karch, MD Vol#: 346

EMC 474 United Metabolic Research Center, Inc Vol#: 346

EMC 475 United Metabolic Research Center, Inc Vol#: 346

EMC 476 Marian C Callahan MS, LAc Vol#: 346

EMC 477 Kenneth Quick Vol#: 346

EMC 478 Linda M. Gibbs Vol#: 346

EMC 479 Chris Post Vol#: 346

EMC 480 Cynthia Dameron, RD Vol#: 346

EMC 481 Rosemary Auclair Vol#: 346

EMC 482 Jeremy Dalton "jd" Vol#: 346

EMC 483 Janice L. Sindler Vol#: 346

EMC 484 Kirk Fellows Vol#: 346

EMC 485 Tim Berry MD Vol#: 346

EMC 486 Howard Haber Vol#: 346

EMC 487 Terrance J Miller Vol#: 346

EMC 488 Mark Daniel Edwards Vol#: 346

EMC 489 Noma Davis Vol#: 346

EMC 490 Marcellino d'Ambrosio PhD Vol#: 346

EMC 491 Frank Monroe Burdett Vol#: 346

EMC 492 Lynn M. Johnson Vol#: 346

EMC 493 Regina Cordell Vol#: 346

EMC 494 Chuck Prince Vol#: 346

EMC 495 Tina Dreher Vol#: 346

EMC 496 John Wilson Vol#: 346

EMC 497 Julian G. Espinosa Vol#: 346

EMC 498 Paula Faulkner Vol#: 346

EMC 499 Patrick Jones DDS Vol#: 346

EMC 500 Marsha Breit Vol#: 346

EMC 501 Flora M Kynard Vol#: 346

EMC 502 Timothy Eugene Ruff Vol#: 346

EMC 503 Dana C. Sherrell Vol#: 346

EMC 504 Mary Dubois RN MBA Vol#: 346

EMC 505 Kay Kreutzer Vol#: 346

EMC 506 Neil Johnson Vol#: 346

EMC 507 Jason Sojka Vol#: 346

EMC 508 Janet Tralla Vol#: 346

EMC 509 Margaret Francis Vol#: 346

EMC 510 Raeann Scheidt Vol#: 346

EMC 511 Kim Ammon Markuly Vol#: 346

EMC 512 Richard R Scheidt Vol#: 346

EMC 513 Gerald Seydel Vol#: 346

EMC 514 Annette Stewart Vol#: 346

EMC 515 Vic Kasturi Vol#: 346

EMC 516 Janet McKenna Vol#: 346

EMC 517 James R Fletcher Vol#: 346

EMC 518 Dr. Jaya Kasturi Vol#: 346

EMC 519 Michael McKenna Vol#: 346

EMC 520 Dennis E. Sandler, MD Vol#: 346

EMC 521 Eleanor Dawson Vol#: 346

EMC 522 Robyn McKenna Vol#: 346

EMC 523 Sue Oakes Vol#: 346

EMC 524 Eileen deJager Vol#: 346

EMC 525 Douglas A. Hassel Vol#: 346

EMC 526 Charles Fleischer Vol#: 346

EMC 527 Diane Badasci-Fortune Vol#: 346

EMC 528 Peggy Palladino Vol#: 346

EMC 529 Nancy Young Vol#: 346

EMC 530 Marlene Halbrook Vol#: 346

EMC 531 Michael Bonanos Vol#: 346

EMC 532 William Cook Vol#: 346

EMC 533 Robert A. McElroy Vol#: 346

EMC 534 Vesna V. Skul, MD Vol#: 346

EMC 535 Renee Cook Garcia Vol#: 346

EMC 536 Nancy R. Bersch-Tomasheski Vol#: 346

EMC 537 Annilise M. Flanagan-Frankl Vol#: 346

EMC 538 William Thomas Saltz Vol#: 346

EMC 539 Ernest S. Frankl Vol#: 346

EMC 540 Sara Aboulhosn Vol#: 346

EMC 541 Paula Jenkins Vol#: 346

EMC 542 John J. Kainady Vol#: 346

EMC 543 Tawnee Lynn Eckhart Vol#: 346

EMC 544 Michael McKay Vol#: 346

EMC 545 Slobodanka Liba Jacobs Vol#: 346

EMC 546 Robin Hanover Vol#: 346

EMC 547 Natalie Thackston Vol#: 346

EMC 548 Richard Cisneros Vol#: 346

EMC 549 Claire Preston Vol#: 346

EMC 550 Harold E Wilson Vol#: 346

EMC 551 Allison Shride Vol#: 346

EMC 552 Neil K. Gertz Vol#: 346

EMC 553 Jane Mead Vol#: 346

EMC 554 Dr Jeff Wynn Vol#: 346

EMC 555 Alex Saenz Vol#: 346

EMC 556 Nancy Sedlock Vol#: 346

EMC 557 Michelle Lynn Durtschi Vol#: 346

EMC 558 Rosie Camp Vol#: 346

EMC 559 Christine R. Armstrong Vol#: 346

EMC 560 Barbara L. McGill Vol#: 346

EMC 561 Richard L. Mueller Vol#: 346

EMC 562 Bonnie Kloepfer Vol#: 346

EMC 563 Harold Roach Vol#: 346

EMC 564 Robert Luedke Vol#: 346

EMC 565 Moshe Dekel MD Vol#: 346

EMC 566 Shannon K. Johnson Vol#: 346

EMC 567 Ashok G. Patel Vol#: 346

EMC 568 Gary M. Jordan Vol#: 346

EMC 569 Stephanie Martinez Vol#: 346

EMC 570 Dr. Darrell Kirby Vol#: 346

EMC 571 Richard Shapiro Vol#: 346

EMC 572 Edward J. Vaughn Vol#: 346

EMC 573 Kendra K. Lipka Vol#: 346

EMC 574 Kerry E. Walsh Vol#: 346

EMC 575 Mark L. McKenzie Vol#: 346

EMC 576 Eric Lipka Vol#: 346

EMC 577 Tom Chic Vol#: 346

EMC 578 Dara G. McLeod Vol#: 346

EMC 579 Wayne Glen Tyni Vol#: 346

EMC 580 Katri Tyni Vol#: 346

EMC 581 Robyn Lennox Vol#: 346

EMC 582 Amy Duncan Vol#: 346

EMC 583 Richard Rose Vol#: 346

EMC 584 Hisayo Hatakeyama Vol#: 346

EMC 585 George F. Zerucha PA-C Vol#: 346

EMC 586 Dane Fajardo Vol#: 346

EMC 587 Carol J. Johnson Vol#: 346

EMC 588 Joe T. Johnson Vol#: 346

EMC 589 Virginia A. Brandon Vol#: 346

EMC 590 Brandon T. Johnson Vol#: 346

EMC 591 Jennifer Jane McGill Vol#: 346

EMC 592 Robert J Hopw Vol#: 346

EMC 593 Teresa Katz Vol#: 346

EMC 594 Jeffrey H. Katz Vol#: 346

EMC 595 Nancy Wetzel Vol#: 346

EMC 596 Dianne Rundell Vol#: 346

EMC 597 Jim Biby Vol#: 346

EMC 598 Joel Petersen Vol#: 346

EMC 599 Bill Petersen Vol#: 346

EMC 600 Belinda Petersen Vol#: 346

EMC 601 Michael Bova Vol#: 346

EMC 602 Mitch Padnos Vol#: 346

EMC 603 Kathryn E. Humecki CPA Vol#: 346

EMC 604 Robert H. Bon Durant Vol#: 346

EMC 605 Dyann Bernard Vol#: 346

EMC 606 Kimberly A. Schnell Vol#: 346

EMC 607 Anthony P Zeurcha RN Vol#: 346

EMC 608 James Burgess Vol#: 346

EMC 609 Fumiko Moeckel Vol#: 346

EMC 610 Steven DiSciullo PhD Vol#: 346

EMC 611 Alison M Sahl RN BSN Vol#: 346

EMC 612 James E. Crittenden Vol#: 346

EMC 613 Robert J. Wagner Jr. Vol#: 346

EMC 614 Sandra J. Cordan Vol#: 346

EMC 615 Gina Boring Vol#: 346

EMC 616 Corinda Giglio Vol#: 346

EMC 617 James Edward Young Vol#: 346

EMC 618 Joanne Jordan Trimpe Vol#: 346

EMC 619 Kristen Gentry Vol#: 346

EMC 620 Beverly Todd Vol#: 346

EMC 621 Sharon O'Neill Vol#: 346

EMC 622 Tony Labella Vol#: 346

EMC 623 Donna Jones Vol#: 346

EMC 624 Debbie Fletcher Vol#: 346

EMC 625 Michael C Brau Vol#: 346

EMC 626 Beverly Brau Vol#: 346

EMC 627 Thomas W. Tanner Vol#: 346

EMC 628 Fran Lovelace Vol#: 346

EMC 629 Jan Luquette Vol#: 346

EMC 630 Ryan Welch Vol#: 346

EMC 631 Sandy Welch Vol#: 346

EMC 632 Jim Gaffney Vol#: 346

EMC 633 Darlene Welch Vol#: 346

EMC 634 Alisha Gaffney Vol#: 346

EMC 635 Deborah Stevens Vol#: 346

EMC 636 Tara Foust Vol#: 346

EMC 637 Bill & Robin Davis Vol#: 346

EMC 638 Heather Davis Vol#: 346

EMC 639 Brandi Maxwell Vol#: 346

EMC 640 Michael Stevens Vol#: 346

EMC 641 Julie Holmes Vol#: 346

EMC 642 Dr Stan Jensen Vol#: 346

EMC 643 Janna Miller Vol#: 346

EMC 644 Stacie Jones RN Vol#: 346

EMC 645 Michael Courtney Brau Vol#: 346

EMC 646 Randy & Kelly Murphy Vol#: 346

EMC 647 Tom Stevens Vol#: 346

EMC 648 Don Page Vol#: 346

EMC 649 Kristi McFarland Vol#: 346

EMC 650 Alicia Bellenger Vol#: 346

EMC 651 Scott E. Musinski MD Vol#: 346

EMC 652 Holly Ruprecht Vol#: 346

EMC 653 Kenneth Gates Vol#: 346

EMC 654 Sharon Jones Vol#: 346

EMC 655 Jan Dennis Vol#: 346

EMC 656 Sharyn Hamilton Vol#: 346

EMC 657 Rhonda Shirley Vol#: 346

EMC 658 Jan Lewellyn Vol#: 346

EMC 659 Dan Fellows Vol#: 346

EMC 660 Tamara S Craig Vol#: 346

EMC 661 Timothy Paul Eba Vol#: 346

EMC 662 September Hakanson Rank Vol#: 346

EMC 663 William O. Ibe Vol#: 346

EMC 664 Neil Levitt Vol#: 346

EMC 665 Kimiko Taoyama Vol#: 346

EMC 666 Devin A. Rogers Vol#: 346

EMC 667 Karin M. Umehara Vol#: 346

EMC 668 Dyan S. Kaufman Vol#: 346

EMC 669 Kathy Howard Vol#: 346

EMC 670 Jos Commandeur Vol#: 346

EMC 671 Jan Commandeur Vol#: 346

EMC 672 Tamala Lester Vol#: 346

EMC 673 Michael Chandler Vol#: 346

EMC 674 Bruce Giglio Vol#: 346

EMC 675 Mojgan Tondravi Vol#: 346

EMC 676 Rachelle K. Zayicek Vol#: 346

EMC 677 Carroll S. Ingersoll Vol#: 346

EMC 678 Thien Van Ha Vol#: 346

EMC 679 Kelli Nguyen RN BSN CCRN Vol#: 346

EMC 680 Thao Nguyen Vol#: 346

EMC 681 Andrew Finkbeiner Vol#: 346

EMC 682 Rance Rogers Vol#: 346

EMC 683 Robert Tolhuijsen Vol#: 346

EMC 684 Tamara Johnson Vol#: 346

EMC 685 David Lasswell Vol#: 346

EMC 686 Satinder K. Ajrawat, MD Vol#: 346

EMC 687 Maggi Mann Vol#: 346

EMC 688 Robert F. Brill MD Vol#: 346

EMC 689 Lynn S. Brill Vol#: 346

EMC 690 Amy Logsdon Vol#: 346

EMC 691 Michael O. Hudgin Vol#: 346

EMC 692 Gwendolyn Poole Vol#: 346

EMC 693 Donna Stout Vol#: 346

EMC 694 Annette Johnston Vol#: 346

EMC 695 Naomi Reed Vol#: 346

EMC 696 Melissa Vol#: 346

EMC 697 Luann Harner Vol#: 346

EMC 698 Larry Eugene Van Gundy Vol#: 346

EMC 699 Barbara Ann Van Gundy Vol#: 346

EMC 700 Kathy Slater Vol#: 346

EMC 701 Kenneth Wightman Vol#: 346

EMC 702 Elizabeth M. Deer Vol#: 346

EMC 703 Martin J. Reilly Vol#: 346

EMC 704 Rodrick & Carolyn Cherry Vol#: 346

EMC 705 Cynthia J. Lewis Vol#: 346

EMC 706 Scott McGill Vol#: 346

EMC 707 Paul Appelbaum Vol#: 346

EMC 708 Wendi Gabriel Vol#: 346

EMC 709 Roy Dewitt Vol#: 346

EMC 710 David Heilferty Vol#: 346

EMC 711 Judith Phillips Vol#: 346

EMC 712 Carolyn Y. Gonzales Vol#: 346

EMC 713 Nancy Teresi Vol#: 346

EMC 714 Ken Nordin Vol#: 346

EMC 715 Barbara Nordin Vol#: 346

EMC 716 Ken Nordin Vol#: 346

EMC 717 Robin L. Fagundes Vol#: 346

EMC 718 Michelle Deherrera Vol#: 346

EMC 719 Catherine Louise Wabeke Vol#: 346

EMC 720 Dr Joel Kravitz Vol#: 346

EMC 721 Cheryl Sutley Vol#: 346

EMC 722 Cyndi M. Verdegaal Vol#: 346

EMC 723 Mary E. Hays Vol#: 346

EMC 724 Chris Blair Vol#: 346

EMC 725 Maria Fleischmann Vol#: 346

EMC 726 John Vravick Vol#: 346

EMC 727 Tonya Brown Vol#: 346

EMC 728 Sandra Ann Fruehe Vol#: 346

EMC 729 Kasara M. B. Gage, Kasara Brennan Vol#: 346

EMC 730 Jeremiah Gage Vol#: 346

EMC 731 Michael J. Mahler Vol#: 346

EMC 732 Manjit Grewal Vol#: 346

EMC 733 James and Mari MacLean Vol#: 346

EMC 734 Julia Smith Vol#: 346

EMC 735 Dept of Defense, US Army Vol#: 346

EMC 736 Cynthia Jayne Leepper Vol#: 346

EMC 737 Glenview Healing Arts Center Vol#: 346

EMC 738 Sherry Braheny MD Vol#: 346

EMC 739 Christina Defibaugh Vol#: 346

EMC 740 Justin M Norris Vol#: 346

EMC 741 Susan Sandler Vol#: 346

EMC 742 Danielle Braun Vol#: 346

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

C 77 Center for Food Safety Vol#: 7

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

C 75 Center for Food Safety Vol#: 7

99F-5322 Ionizing Radiation for the Treatment of Food

C 74 Center for Food Safety Vol#: 5

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

C 78 Center for Food Safety Vol#: 5

00E-1248 Patent Extension Tikosyn (dofetilide) #4,959,366

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

00E-1403 Patent Extension Prevnair, No. 5,360,897

LET 6 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

01E-0031 Patent Extension for EXELON, No. 4,948,807

LET 3 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

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

C 73 Center for Food Safety Vol#: 7

01N-0275 Performance standard for Diagnostic X-Ray Systems & Major Co

C 5 NEMA, Nat. Electrical Mfrs. Assn. Vol#: 1

C 6 State of New Jersey Dept. of Environment Vol#: 1

02D-0018 Race and Ethnicity Data in Clinical Trials for FDA

C 23 CPR for Women & Families Vol#: 1

02E-0021 Patent Term Application for Hyperion LTK Sys. No. 4,976,709

LET 3 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

02E-0343 Patent Term Application for Zevalin No. 5,776,456

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

02E-0345 Patent Term Application for Aromanis No. 4,808,616

LET 3 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

02N-0204 Bar Code Label Requirements for human drug products

C 30 Hollister-Stier Labs. LLC Vol#: 13

02N-0276 Bioterrorism Preparedness;Registration of Food Facilities

C 144 Jen-Coat, Inc. Vol#: 10

C 145 International Pharmaceutical Excipients Vol#: 10

C 146 International Assn of Airport Duty Free Vol#: 10

C 147 SVZ International BV Vol#: 10

C 148 CIAJ Vol#: 10

C 149 Can Manufacturers Institute (CMI) Vol#: 10

C 150 Louis Dreyfus Vol#: 10

C 151 International Warehouse Logistics Assn Vol#: 10

C 152 Reckitt Benckiser, Inc. Vol#: 10

C 153 American Trucking Assn, Inc. (ATA) Vol#: 10

C 154 Form Letters 5 Vol#: 12

02N-0278 Bioterrorism; Prior Notice of Imported Food Shipments

C 206 International Assn of Airport Duty Free Vol#: 12

C 207 New Englad Saefood Producers Assn (NESPA Vol#: 12

C 208 International Pharmaceutical Excipients Vol#: 12

C 209 SVZ International BV Vol#: 12

C 210 Nutraceutical Corporation Vol#: 12

C 211 CIAJ Vol#: 12

C 212 Reckitt Benckiser, Inc. Vol#: 12

C 213 International Foodservice Distributors Vol#: 12

C 214 Jen-Coat, Inc. Vol#: 12

C 215 Andrew & Williamson Sales Co., Inc. Vol#: 12

C 216 Canadian Assn of Importers & Exporters Vol#: 12

C 217 Can Manufacturers Institute (CMI) Vol#: 12

EMC 102 PT, RWTUV Indonesia Vol#: 11

02N-0534 Medical Device User Fee and Modernization Act of 2002

C 21 NEMA, Nat. Electrical Mfrs. Assn. Vol#: 2

C 22 Buford Pusser Vol#: 2

C 23 DMA, Dental Manufacturers of America, In Vol#: 2

03D-0001 Nonclinical Safety Evaluation of Pediatric Drug Products

C 2 Schering-Plough Integrated Therapeutics Vol#: 1

03E-0030 Patent Term Extension Application for FASLODEX No. 4,659,516

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

03E-0031 Patent Extension Application for VFEND No. 5,567,817

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

03E-0032 Patent Term Extension Application for IMAGENT, No. 5,639,443

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

03E-0035 Patent Term Extension Application for ZETIA No. RE37,721

LET 2 HFD-5 to U.S. Patent & Trademark Office Vol#: 1

03N-0017 Risk Management Programs on the Practice of Pharmacy

C 1 PhRMA, Pharmaceutical Res, & Mfrs of Ame Vol#: 1

03V-0156 Laser Light Show

ACK 1 HFA-304 to Epic Beat Production Vol#: 1

VAR 1 Epic Beat Productions Vol#: 1