Table of Contents

SUP 31 Schwarz Pharma, Inc Vol#: 32

96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed

C 1696 Ruth & Arthur Lathrop Vol#: 86

96N-0411 New Animal Drugs for Investigational Use & NADA

C 15 American Assn of Swine Practitioners Vol#: 1

97N-0074 President's National Food Safety Initiative

C 111 Della Oliver Vol#: 10

98D-0481 180-day Generic Drug Exclusivity under Hatch-Waxman Amendmen

C 15 Alfred B. Engelberg Vol#: 1

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 158 Jacqueline Lantheaume Vol#: 19

C 159 John Mohler Jr Vol#: 19

C 160 Mary Ann Burkhalter Vol#: 19

C 161 James R. Wohlford Vol#: 19

EC 9 S. Larson Vol#: 19

98N-0562 Civil Money Penalties; Rajaram K Matkari

CS 2 HFA-305 Vol#: 1

OR 2 HF-3 Vol#: 1

98N-1215 Foreign Establishment Registration and Listing

C 23 Assn of Ontario Medical Manufacturers Vol#: 1

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

C 609 Jenney Gordon Vol#: 24

C 610 Marion Zinowski Vol#: 24

C 611 Stephanie Zinowski Vol#: 24

C 612 Michael & DeAnna Woolston Vol#: 24

C 613 Karen Wolf Vol#: 24

C 614 Kim C. Eaton Vol#: 24

C 615 Roni Lawrence Vol#: 24

C 616 Betty Jean Herner Vol#: 24

C 617 Carole Moomey Vol#: 24

C 618 Lois N. Cox Vol#: 24

C 619 House-Mouse Designs Vol#: 24

C 620 Betty Ford Vol#: 24

C 621 Susan Van Nuys Vol#: 24

C 622 Lee Spears et al Vol#: 24

C 623 Julie O'Donnell Vol#: 24

C 624 Charles Schwamb Vol#: 24

C 625 Michael Gurwitz Vol#: 24

C 626 Paul V. Sapia Vol#: 24

C 627 Jan D. Sinnott, Ph.D. Vol#: 24

C 628 Teresa A. Robinson Vol#: 24

C 629 Elizabeth M. Portelly Vol#: 25

C 630 Candy Colby Vol#: 25

C 631 L. Vurek Vol#: 25

C 632 Elaine F. Livesey-Fassel Vol#: 25

C 633 Bonnie & Robert West Vol#: 25

C 634 Susan Wiedman Vol#: 25

C 635 Patricia Daly Vol#: 25

C 636 Eileen Gottschalk Vol#: 25

C 637 94 signatures Vol#: 25

C 638 O. I. Nash Vol#: 25

C 639 AARP Vol#: 25

C 640 AQIS, Australian Quarantine & Inspection Vol#: 25

C 641 American Veterinary Medical Assn. Vol#: 25

C 642 Maryland Egg Council, Inc. Vol#: 25

C 643 Dolco Packaging Vol#: 25

C 644 The American Dietetic Assn. Vol#: 25

C 645 NERO, National Egg Regulatory Officials Vol#: 25

C 646 Geoffrey E. Doman Vol#: 25

C 647 M. N. O'Sullivan Vol#: 25

C 648 Jerome Mc Collom & Colleen Kronquist Vol#: 25

C 649 Eleanor Maragliana Vol#: 25

C 650 M. Custodio Vol#: 25

C 651 Teresa A. Maragliano Vol#: 25

C 652 Edward Alchastz Vol#: 25

C 653 Sandra L. Giardini Vol#: 25

C 654 Cindy K. Eckleberry Vol#: 25

C 655 Elaine Charkowski Vol#: 25

C 656 Gabrielle Koeferl Vol#: 25

C 657 Susan C. McBiede Vol#: 26

C 658 Patricia Panitz Vol#: 26

C 659 10 signatures Vol#: 26

C 660 Jann & Robert Moorehead Vol#: 26

C 661 Scott & Lori Walker Vol#: 26

C 662 Lois Blumenthal Vol#: 26

C 663 Kristen Krivoshia Vol#: 26

C 664 Sheila M. Richardson Vol#: 26

C 665 Austin Vol#: 26

C 666 Marianne R. Merritt, Esquire Vol#: 26

C 667 Form letter count 75 Vol#: 27

C 668 Form letter count 49 Vol#: 28

C 669 Anne Sacilowski Vol#: 26

C 670 CSPI Vol#: 26

C 671 FMI, Food Marketing Institute Vol#: 26

C 672 Humanitarians of Florida, Inc. Vol#: 26

C 673 Dorothea Mueller Vol#: 26

C 674 Ms Sheila A. Rybak Vol#: 26

C 675 Ms Kari Nienstedt Vol#: 26

C 676 Susan Porto Vol#: 26

C 677 Ronda Styles Vol#: 26

C 678 Helene Schwartz Vol#: 26

C 679 Phil & Sue Ellin Vol#: 26

C 680 12 signatures Vol#: 26

C 681 10 signatures Vol#: 26

C 682 Margaret Murray Vol#: 26

C 683 Lori Thayer Vol#: 26

C 684 Susan M. Troutman Vol#: 26

C 685 E. Brien Vol#: 26

C 686 Lucille Kram Vol#: 26

C 687 no signature Vol#: 26

C 688 Mr. Pat Mezzullo Vol#: 26

C 689 Robin Kapien Vol#: 26

C 690 Linda Williams Vol#: 29

C 691 Joy M. Zakarian, M.P.H. Vol#: 29

C 692 Char Sakamoto Ishii Lum & Ching Vol#: 29

C 693 Lillian Shaver Vol#: 29

C 694 Ruth Kuzub Vol#: 29

C 695 Mary Gilbert Vol#: 29

C 696 Mary Picca Vol#: 29

C 697 Kelly Dovel Vol#: 29

C 698 Yasmin Aziz, Esq. Vol#: 29

EC 5 Karen Davis, Ph.D. Vol#: 25

EC 6 Andy Wadsworth Vol#: 25

EC 7 Mary Finelli Vol#: 25

98N-1265 Distribution of Compounded Drug Products

C 6121 L. Ashworth Vol#: 171

C 6122 Thelma Box Vol#: 171

C 6123 Darla Colvin Vol#: 171

C 6124 S. L. Eagle Vol#: 171

C 6125 Judith Burnett Vol#: 171

98P-0683 Soy Protein Containing Products

C 144 Valerie James Vol#: 21

C 145 Valerie James Vol#: 21

C 146 The Food Commission Vol#: 21

99D-0296 Formal Meetings with Sponsors/Applicant for PDUFA Products

C 6 MERCK Research Laboratories Vol#: 1

99D-0297 Formal Dispute Resolution Appeals above the Division Level

C 3 MERCK Research Laboratories Vol#: 1

99D-1540 Reviewers on Evaluation of Human Pregnancy Outcome Data

NM 1 Vol#: 1

99D-1738 Bioavilability & Bioequivalence Studies for Nasal Aerosols

C 11 Rhone-Poulenc Vol#: 1

C 12 Gardner, Carton & Douglas Vol#: 1

99D-1878 Good Manufacturing Practice for Blood and Blood Components:

C 28 Parkland Memorial Hospital Vol#: 1

99D-2013 Cooperative Manufacturing Arrangements for Licensed

C 2 Bio Science Contract Production Corp Vol#: 1

99D-2152 Device Use Safety: Incorporating Human Factors in Risk

C 1 Technowipe, Inc. Vol#: 1

99H-3060 Civil Money Penalty;7-Eleven Inc,dba 7-Eleven Food Store #19

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3061 Civil Money Penalty;Eads News Inc,dba Eads News & Smoke Shop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3062 Civil Money Penalty;Billy L. Eckstine,dba Myersville Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3063 Civil Money Penalty;Caveline Enterprises Inc,dba Eldersburg

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3064 Civil Money Penalty;CVS of Maryland Inc,dba CVS Pharmacy #15

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3065 Civil Money Penalty;CVS Pharmacy Inc,dba CVS Pharmacy #2172

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3066 Civil Money Penalty;Donald K. McDowell,dba McDowell's Exxon

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3067 Civil Money Penalty;Fred Darling & Jan Darling,dba 7-Eleven

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3068 Civil Money Penalty;George Collins,dba Mc Henry Beverage Sho

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3069 Civil Money Penalty;Gerald Welty,dba 7-Eleven Food Store #29

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3070 Civil Money Penalty;Guillermo Balderas,dba 7-Eleven Food Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3071 Civil Money Penalty;Malik H. Latif,dba 7-Eleven Food Store #

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3072 Civil Money Penalty;Mike Benward & Jack Hughes,dba Short Sho

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-3073 Civil Money Penalty;NAN Corporation,dba Kwik Way Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99N-0193 Supplements and Other Changes to an Approved Application

C 31 GlaxoWellcome Vol#: 3

99N-0671 Manufacture of Whole Blood and Red Blood Cells

C 1 Southeastern Community Blood Center Vol#: 1

99N-1591 Animal Drug Availabililty Act; Veterinary Feed Directive

C 3 American Veterinary Medical Association Vol#: 1

C 4 Association of American Feed Control Vol#: 1

C 5 Animal Health Institute Vol#: 1

C 6 National Pork Producers Council Vol#: 1

99N-2670 Antiviral Drugs Advisory Committee

C 1 GlaxoWellcome Vol#: 1

99N-4068 Advisory Opinions; Extension,Collection of Information

N 1 Vol#: 1

99P-2554 Administrative Action Against E. Excel International

C 2 Giauque,Crockett, Bendinger & Peterson Vol#: 10

99P-2630 Establish a Daily Value for "added sugars"

C 62 Amisha Sharma Vol#: 1

C 63 Lisa M. Caylor Vol#: 1

C 64 Berkeley-Orinda Women's Health, Inc. Vol#: 1

C 65 Ethel F. Gordon Vol#: 1

C 66 Robert C. Noble Vol#: 1

C 67 Stanley Rose Vol#: 1

C 68 Barbara T. Bingham Vol#: 1

C 69 Florence Schwartz Vol#: 1