Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on August 28, 2001

TABLE OF CONTENTS

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78N-0224 TRIMETHOBENZAMIDE HYDROCHLORIDE SUPPOSITORIES
78N-036L OTC Laxative *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-2146 Designate Fosamax (alendronate sodium) as an alternate refer
00D-1598 Voluntary Labeling for Bioengineered Foods *
00P-1574 ANDA Suitability Petition for Potassium Lodide 65 mg Tablets *
01P-0190 Fountain Diet Coca-Cola and Bottled Diet Coca-Cola *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0251 ANDA Suitability for Hydrocodone Bitartrate & Acetaminophen
01P-0374 ANDA for Hydrocodone Bitartrate and Acetaminophen Elixir,7.5 *

78N-0224 TRIMETHOBENZAMIDE HYDROCHLORIDE SUPPOSITORIES

WDL 1 King Pharmaceuticals Inc Vol#: 1

78N-0227 Trimethobenzamide Hydrochloride Injection & Capsules

WDL 1 King Pharmaceuticals Inc Vol#: 1

78N-036L OTC Laxative

LET 193 The Triad Group Vol#: 107

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

OB 1 Anonymous Egg Eater Vol#: 31

OB 2 Truman Hall Vol#: 31

OB 3 Glenda Grantham Vol#: 31

OB 4 Daniel Ray Vol#: 31

OB 5 Chuck Friemel Vol#: 31

97P-0197 Require that warning labels about risks of salmonella enteri

OB 1 Anonymous Egg Eater Vol#: 30

OB 2 Truman Hall Vol#: 30

OB 3 Glenda Grantham Vol#: 30

OB 4 Daniel Ray Vol#: 30

OB 5 Chuck Friemel Vol#: 30

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

OB 1 Anonymous Egg Eater Vol#: 32

OB 2 Truman Hall Vol#: 32

OB 3 Glenda Grantham Vol#: 32

OB 4 Daniel Ray Vol#: 32

OB 5 Chuck Friemel Vol#: 32

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

C 5160 Katherine Hanson Vol#: 169

C 5161 Dawn Mallow Vol#: 169

C 5162 Corey P. Mondello Vol#: 169

C 5163 Carrie A. Young Vol#: 169

C 5164 Jackie Kam-Blockard Vol#: 169

C 5165 Shirley O'Connor Vol#: 169

C 5166 Susan B. Gilliam Vol#: 169

C 5167 Rose Reina-Rosenbaum Vol#: 169

99P-2146 Designate Fosamax (alendronate sodium) as an alternate refer

WDL 1 Kirkpatrick & Lockhart LLP Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 8579 C. Culwood Vol#: 438

C 8580 Brenda Crandall Vol#: 438

C 8581 Patricia Snouffer Vol#: 438

C 8582 Meredith M. Lubernau Vol#: 438

C 8583 Vivian Cornacchia Vol#: 438

C 8584 Erika A. Butts Vol#: 438

C 8585 Gloria S. Van Vliet Vol#: 438

C 8586 Donna Boozer Vol#: 438

C 8587 Jeannie Fennell Vol#: 438

C 8588 Rosemary Easley Vol#: 438

C 8589 Mary K. Morton Vol#: 438

C 8590 Angela Kim Gragg Vol#: 438

C 8591 Martin Mondrus Vol#: 438

C 8592 Nora Fisher Vol#: 438

C 8593 Jane Fairbanks Vol#: 438

C 8594 Gilbert H. Kirchner Vol#: 438

C 8595 Amy Anderson Vol#: 438

C 8596 Debra Meredith Vol#: 438

C 8597 Louise Hoban Vol#: 438

C 8598 Rose H. Paret Vol#: 438

C 8599 No Signature Vol#: 438

C 8600 John & June Wilson Vol#: 438

C 8601 Margaret Lynn Shelton Vol#: 438

C 8602 Robert Rhodes Vol#: 438

C 8603 Myra Thornton Vol#: 438

C 8604 David E & Julia M Davis Vol#: 438

C 8605 J. King Vol#: 438

C 8606 Leslie Law-Morstatt Vol#: 438

C 8607 Leslie Law-Morstatt Vol#: 438

C 8608 Joseph S. Halapi Vol#: 438

C 8609 Eligible Vol#: 438

C 8610 Kathy A. Jabs Vol#: 438

C 8611 V. Bucko Vol#: 438

C 8612 Jude Milano Vol#: 438

C 8613 Jeanne Herzer Vol#: 438

C 8614 Cynthia L. Gay Vol#: 438

C 8615 Ruth Van Acker Vol#: 438

C 8616 Loyd Campbell Vol#: 438

C 8617 Barbara Paul Vol#: 438

C 8618 Robert Hardy Vol#: 438

C 8619 Paula Krolikoski Vol#: 438

C 8620 Bhanu J. Harrison Vol#: 438

C 8621 B. Adams Vol#: 438

C 8622 Jo Edmisten Vol#: 438

C 8623 Mary Lou Wooten Vol#: 438

C 8624 Jackie G. Heronx Vol#: 438

C 8625 Charles R. Petersen Vol#: 438

C 8626 Shirley Riley Vol#: 438

C 8627 Luella Gruchalla Vol#: 438

C 8628 Audra Macomber Vol#: 438

C 8629 Patrick Bretz Vol#: 438

C 8630 Bettina Voelk Vol#: 438

C 8631 Nancy Broberg Vol#: 438

C 8632 Emily Ostapovitch Vol#: 438

C 8633 Carol Dupuis Vol#: 438

C 8634 Pamela Ann Cabral Vol#: 438

C 8635 Ronald M. Heard Vol#: 438

C 8636 Marsha Melder Vol#: 438

C 8637 Donald E & Judith A Hudgins Vol#: 438

C 8638 Thelma S. Taylor Vol#: 438

C 8639 Don & Sandra Runge Vol#: 438

C 8640 Karen Coffin Vol#: 438

C 8641 Kathy Woodall Vol#: 438

C 8642 Merle Pieterse Vol#: 438

C 8643 Phyllis Diane Gibbs Vol#: 438

C 8644 Robin Walter Vol#: 438

C 8645 Kathryn E. Mullis Vol#: 438

C 8646 Mary R. Hawkino Vol#: 438

C 8647 Catherine Abbott Vol#: 438

C 8648 Susan Pelakh Vol#: 438

C 8649 Dorothy C. Hatchett Vol#: 438

C 8650 Haru Alberti Vol#: 438

C 8651 Theresa Rucker Vol#: 439

C 8652 Kay Smith Vol#: 439

C 8653 Vicki Katuin Vol#: 439

C 8654 Marion R. Smith Vol#: 439

C 8655 Bonnie V. Hartian Vol#: 439

C 8656 Kevin & Ann Jongsma Vol#: 439

C 8657 W.S. Woods Vol#: 439

C 8658 Garrett Jackson Vol#: 439

C 8659 Susan Kozlevcar Vol#: 439

C 8660 Marc Waller Vol#: 439

C 8661 Lynda Batson Vol#: 439

C 8662 JoAnne Meyer Vol#: 439

C 8663 Brian K. Pualters Vol#: 439

C 8664 William C. Whitman Vol#: 439

C 8665 Mary Faky Vol#: 439

C 8666 Colleen Schnack Vol#: 439

C 8667 Ellen Dessloch Vol#: 439

C 8668 Jean & Mike Rosendale Vol#: 439

C 8669 Mr & Mrs Travis A. Allison Vol#: 439

C 8670 Cheryl Jackson Vol#: 439

C 8671 Shirley Magnani Vol#: 439

C 8672 Robert Selle Vol#: 439

C 8673 Maria Santillanes Vol#: 439

C 8674 Michele Reiche Vol#: 439

C 8675 Michael G. Fleck Vol#: 439

C 8676 Dr. Maryalice Steller-Stevenson Vol#: 439

C 8677 Kathy Todd Vol#: 439

C 8678 Lilia U. Pardo Vol#: 439

C 8679 Janet B. Mascitelli Vol#: 439

C 8680 Naomi Lauck Vol#: 439

C 8681 Elizabeth Minney Vol#: 439

C 8682 Marcia Duncan Vol#: 439

C 8683 Della Cory Vol#: 439

C 8684 Bob & Ann Quinn Vol#: 439

C 8685 Bryant Renke Vol#: 439

C 8686 G. Cuntia Vol#: 439

C 8687 C. Hall Vol#: 439

C 8688 Elsie Wyman Vol#: 439

C 8689 Sue Harris Vol#: 439

C 8690 Ernest C. Hardsaw Vol#: 439

C 8691 Dennis Bonfiglio Vol#: 439

C 8692 Doris Mack Vol#: 439

C 8693 Charles & Darlene Crawford Vol#: 439

C 8694 Nancy Jeffers Vol#: 439

C 8695 B.J. Micetich Vol#: 439

C 8696 Margery M. Rosa Vol#: 439

C 8697 Cindy Hill Vol#: 439

C 8698 Kevin D. Nicholson Vol#: 439

C 8699 Anne Ortega Vol#: 439

C 8700 Wade & Sandy Hartman Vol#: 439

C 8701 Tracey L. Valentine Vol#: 439

C 8702 Pauline Napke Vol#: 439

C 8703 R.L. Wheelock Vol#: 439

C 8704 Anabel M. Viscuso Vol#: 439

C 8705 Jerry Swain Vol#: 439

C 8706 Carlene Parson Vol#: 439

C 8707 Nancy Rubin Vol#: 439

C 8708 Harley G. Johnson Vol#: 439

C 8709 Helen Roberts Vol#: 439

C 8710 Lorrain Johnson Vol#: 439

C 8711 Rosemary Kramer Vol#: 439

C 8712 Donald W. Tew Vol#: 439

C 8713 Helen Bartley Vol#: 439

C 8714 Shirley Enget Vol#: 439

C 8715 Joan Lippke Vol#: 439

C 8716 Lawrence J. Zucal Vol#: 439

C 8717 Kathleen Hampton Vol#: 439

C 8718 Brent & JoAnne Reed Vol#: 439

C 8719 Sandra Herr Vol#: 439

C 8720 Susan & George Dragan Vol#: 439

C 8721 Gloria L. Wasserman Vol#: 439

C 8722 Wanda Sturgeon Vol#: 439

C 8723 Sarah Kasprzak Vol#: 439

C 8724 Barteau N. Burke Vol#: 439

C 8725 Pat Panticello Vol#: 439

C 8726 Jose O. Martinez Vol#: 439

C 8727 Shelly Stobbelaar Vol#: 439

C 8728 Bonnie L. Heiser Vol#: 439

C 8729 Nissa L. Tinker-Sackett Vol#: 439

C 8730 Diane Whitmire Vol#: 439

C 8731 Y. LeBris Vol#: 439

C 8732 Sharon Balin Vol#: 439

C 8733 Lois G. Dunbar Vol#: 439

C 8734 James C. Brown Vol#: 439

C 8735 Cathryn Wolfrey Vol#: 439

C 8736 Nancy Hartwell Vol#: 439

C 8737 Jacqueline Bishop Vol#: 439

C 8738 Clem C. Brentley Vol#: 439

C 8739 Linda Naiser Vol#: 439

C 8740 Reema Khan Vol#: 439

C 8741 Shawna Hoebing-Didlake Vol#: 439

C 8742 Susan Harkins Vol#: 439

C 8743 Lisa J. DeKramer Vol#: 439

C 8744 Marsha Asbury Vol#: 439

C 8745 Diane Whitmire Vol#: 439

C 8746 Joseph Purcell Vol#: 439

C 8747 Delbert J. Asbury Vol#: 439

C 8748 Susan M. Flint Vol#: 439

C 8749 Theresa Strelberg Vol#: 439

C 8750 Velma J. Burkinskaw Vol#: 439

C 8751 Ron Knapmiller Vol#: 439

C 8752 Paul & Bonnie Trowbridge Vol#: 439

C 8753 Ann M. Harness Vol#: 439

C 8754 Gail Reed Vol#: 439

C 8755 Joel & Marcee Musgrove Vol#: 439

C 8756 Sandra Kag Nevuis Vol#: 439

C 8757 Tracey J. Foster Vol#: 439

C 8758 Judy A. Mink Vol#: 439

C 8759 Elizabeth A. Rehnann Vol#: 439

C 8760 Cynthia Kobak Vol#: 439

C 8761 Elizabeth A. Rehnann Vol#: 439

C 8762 Sandra E. Beyerle Vol#: 439

C 8763 James A. Sanders Vol#: 439

C 8764 Barbara Slater Vol#: 439

C 8765 Patricia E. Zakocs Vol#: 439

C 8766 Judith A. Kemp Vol#: 439

C 8767 Adelheid G. Lucas-W Vol#: 439

C 8768 Jean Konnerth Vol#: 439

C 8769 Carin Johnson Vol#: 439

C 8770 Sheila Aordkiau Vol#: 439

C 8771 No signature Vol#: 439

C 8772 Susan M. Brown-Millering Vol#: 439

C 8773 Lewis Austin Vol#: 439

C 8774 Ida S. Abbott Vol#: 439

C 8775 Joseph Kuyoth Vol#: 439

C 8776 Liane Venzke Vol#: 439

C 8777 Diane Lowen Vol#: 439

C 8778 Mary E. Bush Vol#: 439

C 8779 Veroica Foskett Vol#: 439

C 8780 M.L. Chaffin Vol#: 439

C 8781 Constance Walter Vol#: 439

C 8782 Joyce H. Mix Vol#: 439

C 8783 Paul Weaver, Jr. Vol#: 439

C 8784 Lisa Magliano Vol#: 439

C 8785 Patricia A. Herren Vol#: 439

C 8786 Morma Hamm Vol#: 439

C 8787 James A. Mitchell Vol#: 439

C 8788 Dorothy Kronschnabel Vol#: 439

C 8789 Lona E. Robillard Vol#: 439

C 8790 Joan Carstensen Vol#: 439

C 8791 Beth Westburg Vol#: 439

C 8792 Raymond & Elaine Chester Vol#: 439

C 8793 B.J. Ermolovich Vol#: 439

C 8794 Betty S. Bratton Vol#: 439

C 8795 S. Wilson Vol#: 439

C 8796 Linda & Harvey Hawn Vol#: 439

C 8797 Matthew B. Ransom Vol#: 439

C 8798 Jeff Stiklickas Vol#: 439

C 8799 Gilda Block Vol#: 439

C 8800 Maysellea Duvall Vol#: 439

C 8801 Dianne L. Ascosta Vol#: 461

C 8802 Honne Van Haitsma Vol#: 461

C 8803 Emory Gillespie Vol#: 461

C 8804 Sara Reimer Vol#: 461

C 8805 No signature Vol#: 461

C 8806 Janice Tubiolo Vol#: 461

C 8807 Carol Winguier Vol#: 461

C 8808 Margaret Rodriguez Vol#: 461

C 8809 Vanita Gnpta & Josh Hajicfk Vol#: 461

C 8810 Ann Raley Vol#: 461

C 8811 W.K. Barwell Vol#: 461

C 8812 Billis Darnell Vol#: 461

C 8813 Gary B. Hunnell Vol#: 461

C 8814 Vivian Marie Rarirez Vol#: 461

C 8815 Ivan H. King Vol#: 461

C 8816 Janet M. Herriott Vol#: 461

C 8817 Mark Peabody Vol#: 461

C 8818 Richard M. Bickford Vol#: 461

C 8819 Dorothy E. Stewart Vol#: 461

C 8820 Carolyn Bergeron Vol#: 461

C 8821 Biridgette S. Walker Vol#: 461

C 8822 Angela Maass Steintamp Vol#: 461

00P-1499 Remove alosetron (Lotronex) from the market

C 171 Verna Eileen Radcliffe + others Vol#: 5

00P-1574 ANDA Suitability Petition for Potassium Lodide 65 mg Tablets

SUP 1 Recip AB, c/o R & R Registrations Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

C 101 Federation of the State Medical Board of Vol#: 5

C 102 Brian R Buinewicz MD Vol#: 5

C 103 Reflex Sympathetic Dystrophy Syndrome As Vol#: 5

C 104 Lucio S Villa-Real MD Vol#: 5

C 105 American Academy of Family Physicians Vol#: 5

C 106 Dayton Pain and Preventive Medicine Ltd Vol#: 5

C 107 Mel Stein Vol#: 5

C 108 Rehabilitation Team West PA Vol#: 5

C 109 Duke University Medical Center Vol#: 5

C 110 Jerry Hauser Vol#: 5

C 111 Madeline A Ashley RN Vol#: 5

C 112 Metrowest Oral Surgical Associates Vol#: 5

C 113 National Rehabilitation Hospital Vol#: 5

C 114 Care Center Vol#: 5

C 115 Lake Chelan Clinic PC Vol#: 5

C 116 Catherine Rice Vol#: 5

C 117 Rehabilitation Team West Vol#: 5

C 118 Subacute Care Center of Southern MD Vol#: 5

C 119 Piedmont Anesthesia and Pain Consultants Vol#: 5

C 120 Southern California Cancer Pain Initiati Vol#: 5

C 121 Franklin Vol#: 5

C 122 Baystate Medical Center Vol#: 5

C 123 Margaret Pettey Vol#: 5

C 124 Genellen Winkler Vol#: 5

C 125 Andres Salazar MD Vol#: 5

C 126 Letters Re: Joan Lewis MD Vol#: 5

C 127 Duke University Medical Center Vol#: 6

C 128 Lorraine Powers Vol#: 6

C 129 Richard R Burch Vol#: 6

C 130 Julianne W Chitdold Vol#: 6

C 131 Dexter D Koons MD PC Vol#: 6

C 132 Daniel Goldberg Vol#: 6

C 133 Elizabeth Raymond Sapp Vol#: 6

C 134 Pain Assessment & Rehabilitation Center Vol#: 6

C 135 Elizabeth Schwartz Vol#: 6

C 136 Community Family Mediiicine & Obstetrics Vol#: 6

C 137 James P Senter MD PC Vol#: 6

C 138 John E Flannery MD PhD Vol#: 6

C 139 Franklyn H Folts Vol#: 6

C 140 Curtiss Consulting Vol#: 6

C 141 American Chronic Pain Association Vol#: 6

C 142 Hematology Oncology Northwest PC Vol#: 6

C 143 Mary Jo Campbell Vol#: 6

C 144 Vicki S Jones Vol#: 6

C 145 Pulmonary Speciaalties PC Vol#: 6

C 146 Number not used Vol#: 6

C 147 Dennis Grundy Vol#: 6

C 148 James O'Hara Vol#: 6

C 149 Leon H Chandler Jr MD Vol#: 6

C 150 Nancy Clark Vol#: 6

C 151 Arthritis Northwest Rheumaatology Vol#: 6

C 152 Gloria Steffens Stierer Vol#: 6

C 153 Becky VanGorda Vol#: 6

C 154 Rev Dr Roger John Ofander Vol#: 6

EMC 70 Ginger Vol#: 2

EMC 71 Debra Allen Vol#: 2

EMC 72 Susan Porter Vol#: 2

EMC 73 Sarah Murray Vol#: 2

EMC 74 William S Swann Vol#: 2

EMC 75 Beverly Barry Vol#: 2

EMC 76 William S Swann Vol#: 2

EMC 77 Number not used Vol#: 2

EMC 78 Larry Pokojski Vol#: 2

EMC 79 Number not used Vol#: 2

EMC 80 Number not used Vol#: 2

EMC 81 Brenda Varney Vol#: 2

EMC 82 Number not used Vol#: 2

EMC 83 Number not used Vol#: 2

EMC 84 Interstitial Cysstitis Association Vol#: 2

EMC 85 Bonnie Renzi Vol#: 2

EMC 86 The Connecticut Hospice Inc Vol#: 2

EMC 87 Robert W Yates Vol#: 2

EMC 88 Robert R Yates Vol#: 2

EMC 89 Barbara Ziegler Palliative Care Program Vol#: 2

EMC 90 Edward J Walko DO Vol#: 2

EMC 91 Rebecca Yates Vol#: 2

EMC 92 Bobbits Vol#: 2

EMC 93 BobbitsRep Vol#: 2

EMC 94 Paine Management Resource Vol#: 2

EMC 95 Michael H Moskowitz MD MPH Vol#: 2

EMC 96 Philosophy Dept. OK City University Vol#: 2

EMC 97 Deborah Page Vol#: 2

EMC 98 Scott M Peterson Vol#: 2

EMC 99 Carol Morrison-Petrie Vol#: 2

EMC 100 Linda A Doreck, Johnny W Ledford Vol#: 2

EMC 101 Michael P Ambrose Vol#: 2

EMC 102 Abraham Kryger DMD MD Vol#: 2

EMC 103 Linda Schickendanz RN MSN Vol#: 2

01P-0169 Access & Safe Distribution of Alosetron

C 107 Mary M Polito Vol#: 3

01P-0190 Fountain Diet Coca-Cola and Bottled Diet Coca-Cola

AMD 1 Judy Zapka & Center for Food Safety Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 164 Inge Szucs Vol#: 9

C 165 Form Letter count 20 Vol#: 20

C 166 Form Letter count 40 Vol#: 21

01P-0251 ANDA Suitability for Hydrocodone Bitartrate & Acetaminophen

WDL 1 Mallinckrodt, Inc. Vol#: 1

01P-0259 Refuse to approve tegaserod (Zelmac)

C 10 Gloria Swanson Vol#: 1

01P-0374 ANDA for Hydrocodone Bitartrate and Acetaminophen Elixir,7.5

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Service, Inc Vol#: 1