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Dockets Management
Dockets Entered On December 12, 2003
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1998D-1146 Microbial effects of antimicrobial new animal drugs/human sa
2000N-1396 Bioengineered Foods Consumed By Humans or Animals
2000N-1652 Human Prescripton Drugs/Biologics in Electronic Format
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
2002D-0428 Information for the use of Human Blood & Blood Components
2003N-0084 Electronic Records;Electronic Signatures;Agency Information
2003N-0308 CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
2003N-0324 New Animal Drugs; Removal of Obsolete and Redundant Regulations
2003N-0324B Bacitracin methylene disalicylate single-ingredient Type A Medicated articles
2003N-0324N Combination drug Type B and TYpe C medicated feeds for poultry containing nicarbazin
2003N-0324O Oxytetracycline and neomycin fixed-combination Type A medicated articles
2003N-0324Z Combination drug Type B and Type C medicated feeds for poultry containing bacitracin zinc
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
2003P-0511 refrain from completing the review of the PMA submitted by Inamed Corporation(Inamed) for McGhan silicone gel-filled breast implants
2003P-0530 Silicone Gel-filled Breast Implants
2003P-0556 ANDA for Dihydroergotamine Mesylate Injection
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 11917 Ancient Sun Nutrition, Inc. Vol #: 94
LET 11918 Knature Corporation Vol #: 94
LET 11919 Knature Corporation Vol #: 94
LET 11920 Integrative Therapeutics Inc. Vol #: 94
LET 11921 Your Vitamins Vol #: 94
LET 11922 Worldwide Sport Nutrition Supplements, Inc. Vol #: 94
LET 11923 Worldwide Sport Nutrition Supplements, Inc. Vol #: 94
LET 11924 Worldwide Sport Nutrition Supplements, Inc. Vol #: 94
LET 11925 Met-Rx USA, Inc. Vol #: 94
LET 11926 Met-Rx USA, Inc. Vol #: 94
LET 11927 PhytoPharmica Matural Medicines Vol #: 94
LET 11928 PhytoPharmica Natural Medicines Vol #: 94
LET 11929 PhytoPharmica Natural Medicines Vol #: 94
1998D-1146 Microbial effects of antimicrobial new animal drugs/human sa
EMC 703 B Anderson Vol #: 62
EMC 704 A Croymans Vol #: 62
2000N-1396 Bioengineered Foods Consumed By Humans or Animals
ANS 1 HFS-822 to Ms. Regina Lopez Vol #: 415
C 9557 Regina Lopez Vol #: 415
2000N-1652 Human Prescripton Drugs/Biologics in Electronic Format
NFR 1 FDA Vol #: 1
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EMC 539 Kathleen Bohrer Vol #: 120
EMC 540 Sandy Conley Vol #: 120
EMC 541 Andrea Wolper Vol #: 120
EMC 542 Judy Lyman Vol #: 120
EMC 543 Laurie Warlick Vol #: 120
EMC 544 Kathryn Denise Vol #: 120
EMC 545 Carol Holding Vol #: 120
EMC 546 Jan Stern Vol #: 120
EMC 547 Tiernan Doyle Vol #: 120
EMC 548 Lisa Jerome Vol #: 120
EMC 549 Michelle Eytcheson Vol #: 120
EMC 550 Laura Girardeau, MS Vol #: 120
EMC 551 Melissa Montgomery Vol #: 120
EMC 552 Kate Bell Vol #: 120
EMC 553 Sharon Hanna Vol #: 120
EMC 554 Cat Weatherup Vol #: 120
EMC 555 Sherri Burns Vol #: 120
EMC 556 Julie Zaborovsky Vol #: 120
EMC 557 Stephanie Warm Vol #: 120
EMC 558 Sarah Hauser Vol #: 120
EMC 559 Judy Caughlin Vol #: 120
EMC 560 Valerie Burnette Vol #: 120
EMC 561 Linnea Marx Vol #: 120
EMC 562 Patricia Bielke Vol #: 120
EMC 563 Roxana Rockwell Vol #: 120
EMC 564 Paula Laube Vol #: 120
EMC 565 Bari Pearlman Vol #: 120
EMC 566 Russell Smith Vol #: 120
EMC 567 Jill Zahner Vol #: 120
EMC 568 Robert Wyman Vol #: 120
EMC 569 Mary Firmani Vol #: 120
EMC 570 Beatrijs DeWaard Vol #: 120
EMC 571 Carol Baldwin Vol #: 120
EMC 572 Ellen Seebacher Vol #: 120
EMC 573 Donna Chato Vol #: 120
EMC 574 Frances M. Cone Vol #: 120
EMC 575 Heather Keene Vol #: 120
EMC 576 Erin Harris Vol #: 120
EMC 577 Kate Keilman Vol #: 120
EMC 578 Kelda Roys Vol #: 120
EMC 579 Sheila Curtis Vol #: 120
EMC 580 Shaina Gross Vol #: 120
EMC 581 Eilene Glasgow Vol #: 120
EMC 582 Jeanne Swadosh Vol #: 120
EMC 583 Judith A. Blenden Vol #: 120
EMC 584 Meghan Morse Vol #: 120
EMC 585 Courtney Thomas Vol #: 120
EMC 586 Kirsten Pederson Vol #: 120
EMC 587 Lucille Lewis Johnson Vol #: 120
EMC 588 Lynn Kearney Vol #: 120
EMC 589 Bridget Czapor Vol #: 120
EMC 590 Janice Rael Vol #: 120
EMC 591 Lorenzo Barrera Vol #: 120
EMC 592 Harley McAdams Vol #: 120
EMC 593 Brenda Thompson Vol #: 120
EMC 594 Suzanne Magnuson Vol #: 120
EMC 595 Linda Sullivan Vol #: 120
EMC 596 Robert Rouse Vol #: 120
EMC 597 Catherine Adamson Vol #: 120
EMC 598 Jay Libove Vol #: 120
EMC 599 Neil Stahl Vol #: 120
EMC 600 Anah Sikorsky Vol #: 120
EMC 601 Rev David A. Ames Vol #: 120
EMC 602 Daniela Stevens Vol #: 120
EMC 603 Susan Feightner Vol #: 120
EMC 604 Rick Herring Vol #: 120
EMC 605 Shirley Cofresi Vol #: 120
EMC 606 Charisse Castagnoli Vol #: 120
EMC 607 Kati Irons Vol #: 120
EMC 608 Melanie Lovato Vol #: 120
EMC 609 Frederick Sears Vol #: 120
EMC 610 Jocelyn Blake Vol #: 120
EMC 611 Marcena Love Vol #: 120
EMC 612 Judith Moor Vol #: 120
EMC 613 Ellen Cline Vol #: 120
EMC 614 Cynthia Ann Rose Vol #: 120
EMC 615 Patricia Morgan Vol #: 120
EMC 616 Becky Berry Vol #: 120
EMC 617 Hilary Emmons Vol #: 120
EMC 618 Kirk Lynn Vol #: 120
EMC 619 Pat Buckley, ND Vol #: 120
EMC 620 Bree Dalager Vol #: 120
EMC 621 Charlene Levesque Vol #: 120
EMC 622 Jolinda Smith Vol #: 120
EMC 623 Lora Lee Vol #: 120
EMC 624 Kianna LeVay Vol #: 120
EMC 625 Glen Corso Vol #: 120
EMC 626 Brandy Menefee Vol #: 120
EMC 627 Joan Dulberg Vol #: 120
EMC 628 Doni Mae Vol #: 120
EMC 629 Lauren Schmidt Vol #: 120
EMC 630 Kelly Rusinack Vol #: 120
EMC 631 Swanson Erik Vol #: 120
EMC 632 Jim Allen Vol #: 120
EMC 633 Frances Roehm Vol #: 120
EMC 634 Gail Fadina Vol #: 120
EMC 635 Michelle Des Roches Vol #: 120
EMC 636 Christine Warren Vol #: 120
EMC 637 Elaine Baumgartel Vol #: 120
EMC 638 Peter Bernstein Vol #: 120
EMC 639 Lynne Weiss Vol #: 120
EMC 640 Arnold Ismach Vol #: 120
EMC 641 Eric Schindler Vol #: 120
EMC 642 Erin Hughes Vol #: 120
EMC 643 Larry Bogdanow Vol #: 120
EMC 644 Ben Young Vol #: 120
EMC 645 G. Trystn Taylor Vol #: 120
EMC 646 Jackie Haskins Vol #: 120
EMC 647 Elizabeth Deland Vol #: 120
EMC 648 Aldeen Enright Vol #: 120
EMC 649 Joanna Jansen Vol #: 120
EMC 650 Kathy Hansen Vol #: 120
EMC 651 Erin Vallicelli Vol #: 120
EMC 652 Jennifer Von Eiff Vol #: 120
EMC 653 Vicki Bacon-Husband Vol #: 120
EMC 654 Margaret Francis Vol #: 120
EMC 655 Harold Schulman Vol #: 120
EMC 656 Bob Johnson Vol #: 120
EMC 657 Kristina Meshelski Vol #: 120
EMC 658 Helen S. Cawood Vol #: 120
EMC 659 Carri Nickles Vol #: 120
EMC 660 Paula Bohan DeMore Vol #: 120
EMC 661 Judy Johnson Vol #: 120
EMC 662 Margie Wirth Vol #: 120
EMC 663 Linda Gilbert Vol #: 120
EMC 664 Megan Jones Vol #: 120
EMC 665 Nettie Scott Vol #: 120
EMC 666 Linda McManus Vol #: 120
EMC 667 Shelly Berg Vol #: 120
EMC 668 Jean Daniels Vol #: 120
EMC 669 Kristine Sjultz Vol #: 120
EMC 670 Steve Ko Vol #: 120
EMC 671 Rosilind Gutterson Vol #: 120
EMC 672 Nancy Lemrow Vol #: 120
EMC 673 Gregory Campbell Vol #: 120
EMC 674 Debbi Gibson Vol #: 120
EMC 675 Dru Carter Vol #: 120
EMC 676 Reta A. Madsen Vol #: 120
EMC 677 Wilma Wheeler Vol #: 120
EMC 678 Martin Michaelson Vol #: 120
EMC 679 Susan Rice Vol #: 120
EMC 680 Alyssa Stone Vol #: 120
EMC 681 Elizabeth LaGrua Vol #: 120
EMC 682 K. Munjee Vol #: 120
EMC 683 Nancy Loeser Vol #: 120
EMC 684 Maura Shuttleworth Vol #: 120
EMC 685 Buffy Bourque Vol #: 120
EMC 686 Sue Schlesinger Vol #: 120
EMC 687 Cheryl Kahn Vol #: 120
EMC 688 Rene Bane Vol #: 120
EMC 689 Nathalie Han Vol #: 120
EMC 690 Pirkko Borland Vol #: 120
EMC 691 Stephanie Longfellow Vol #: 120
EMC 692 Rebecca Stewart Vol #: 120
EMC 693 Lauren C. Stringer Vol #: 120
EMC 694 Alisa Lipski Vol #: 120
EMC 695 Michael Monroe Vol #: 120
EMC 696 Sue Christiansen Vol #: 120
EMC 697 Elana Wolowitz Vol #: 120
EMC 698 Karen Cowles Vol #: 120
EMC 699 Karin Anderson Vol #: 120
EMC 700 Judy Hill Vol #: 120
EMC 701 Michael Kinser Vol #: 120
EMC 702 Aliza Kaliski Vol #: 120
EMC 703 Angla Sapienza Vol #: 120
EMC 704 Erin McAlister Vol #: 120
EMC 705 Marcy Stanley Vol #: 120
EMC 706 Matthew Nadelhaft Vol #: 120
2002D-0428 Information for the use of Human Blood & Blood Components
GDL 2 Guideline Vol #: 1
NAD 2 FDA Vol #: 1
2003N-0084 Electronic Records;Electronic Signatures;Agency Information
NAL 1 FDA Vol #: 1
SS 1 SUPPORTING STATEMENT Vol #: 1
2003N-0308 CIVIL MONEY PENALTIES HEARINGS; MAXIMUM PENALTY AMOUNTS AND Compliance with the FEDERAL CIVIL PENALTIES Inflation Adjustment Act
EMC 1 B Sachau Vol #: 1
2003N-0324 New Animal Drugs; Removal of Obsolete and Redundant Regulations
ANS 1 HF-11 to Buchanan Ingersoll Vol #: 1
2003N-0324B Bacitracin methylene disalicylate single-ingredient Type A Medicated articles
ANS 1 HF-11 to Buchanan Ingersoll Vol #: 1
CR 1 Pennfield Oil Company/Pennfield Animal Health Vol #: 1
CR 2 Pennfield Oil Company/Pennfield Animal Health Vol #: 1
EXT 1 Pennfield Oil Company/Pennfield Animal Health Vol #: 1
HER 1
Attachment
Pennfield Oil Company/Pennfield Animal Health Vol #: 1
HER 2 Alpharma Inc. Vol #: 1
LET 1 HFV-1 to Buchanan Ingersoll Vol #: 1
NCR 1 FDA Vol #: 1
NPH 1 FDA Vol #: 1
SF 1 GCF-1 (Separation of Functions) Vol #: 1
SUP 1 Pennfield Oil Company Vol #: 2
SUP 2 Alpharma Inc. Vol #: 6
2003N-0324N Combination drug Type B and TYpe C medicated feeds for poultry containing nicarbazin
NCR 1 FDA Vol #: 1
NPH 1 FDA Vol #: 1
SF 1 GCF-1 Separation of Functions Vol #: 1
2003N-0324O Oxytetracycline and neomycin fixed-combination Type A medicated articles
ANS 1 HF-11 to Buchanan Ingersoll Vol #: 1
CR 1 Pennfield Oil Company/Pennfield Animal Health Vol #: 1
CR 2 Pennfield Oil Company/Pennfield Animal Health Vol #: 1
EXT 1 Pennfield Oil Company/Pennfield Animal Health Vol #: 1
HER 1
Attachment
Pennfield Oil Company/Pennfield Animal Health Vol #: 1
HER 2 Alpharma Inc Vol #: 1
LET 1 HFV-1 to Buchanan Ingersoll Vol #: 1
NCR 1 FDA Vol #: 1
NPH 1 FDA Vol #: 1
SF 1 GCF-1 Separation of Functions Vol #: 1
SUP 1 Pennfield Oil Company/Pennfield Animal Health Vol #: 2
2003N-0324Z Combination drug Type B and Type C medicated feeds for poultry containing bacitracin zinc
NCR 1 FDA Vol #: 1
NPH 1 FDA Vol #: 1
SF 1 GCF-1 Separation of Functions Vol #: 1
2003P-0479 Allow importation of Canadian versions of drugs that are approved to the United States
ACK 2 HFA-305 to State of Vermont, Agency of Administration Vol #: 1
CP 2 State of Vermont, Agency of Administration Vol #: 1
2003P-0511 refrain from completing the review of the PMA submitted by Inamed Corporation(Inamed) for McGhan silicone gel-filled breast implants
PDN 1 HFZ-1 to National Organization for Women et al Vol #: 1
2003P-0530 Silicone Gel-filled Breast Implants
ACK 2 HFA-305 to Worldclient Vol #: 1
CP 2 J Huffman Vol #: 1
2003P-0556 ANDA for Dihydroergotamine Mesylate Injection
ACK 1 HFA-305 to Hyman, Phelps & McNamara, PC Vol #: 1
CP 1
Tab 1, 2
Hyman, Phelps & McNamara, PC Vol #: 1

Page created on December 15, 2003 kk
Page updated January 6, 2004 jb

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