Food and Drug Administration , Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305,  Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 
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DOCKETS ENTERED on July 25, 2000

Table of Contents

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88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
97N-0436 Methods informing consumers of contents of bottle water *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99P-4613 Revoke the Regulation That Approved Posilac *
00N-1256 Over-the-Counter Drug Products;Public Hearing *
00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20 *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00V-1423 Laser Light Show*
88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

ANS 1 HFW-14 to Richard Reeves Vol#: 5

ANS 2 HFW-14 to Stephanie J Gurwitz Vol#: 5

C 122 Grapevine Trading Company Vol#: 5

C 123 National Assoc of Chain Drug Stores Vol#: 5

C 124 Intrn'l Warehouse Logistics Assoc (IWLA) Vol#: 5

C 125 Pharmaceutical Distributors Assoc Vol#: 5

C 126 The Blood Center of Southeastern WI Inc Vol#: 5

C 127 R & S Sales Inc Vol#: 5

C 128 Hemophilia Treatments Centers (HTCs) Vol#: 5

C 129 American Society of Clincal Pathologists Vol#: 5

C 130 America's Blood Centers (ABC) Vol#: 5

C 131 Northern CA Community Blood Bank Vol#: 5

C 132 Intrn'l Academy of Compounding Pharmacis Vol#: 5

C 133 Community Blood Center (CBC) Vol#: 5

C 134 America's Blood Centers (ABC) Vol#: 5

C 135 The Honorable Barbara A Mikulski (CI) Vol#: 5

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 120 The Honorable Barbara A Mikulski (CI) Vol#: 5

97N-0436 Methods informing consumers of contents of bottle water

C 203 L. T. Roberts Vol#: 7
 

98N-0331 Medical Devices;Implementation third party review under FDA

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 780 Cliff Berns Vol#: 28

C 781 Wayland Wong Vol#: 28

C 782 Lea Wood Vol#: 28

EMC 28 Margaret Scrymser Vol#: 28

EMC 29 Cheryl Vallone Vol#: 28

EMC 249 Form letter count (776) Vol#:
 
 

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

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1
 
 

99D-4910 Mammography Quality Standards Act Final Regulations #3

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1
 
 

99H-1586 Civil Money Penalty;Winks of Corolla Inc dba Wink's of Corol

CR 1 GCF-1 Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1
 
 

99H-2604 Civil Money Penalty;T & H Corporation Inc,dba Pitstop Conven

SET 1 GCF-1 Vol#: 1
 
 

99H-2608 Civil Money Penalty;B&D Petroleum Sales Inc,dba AJI Industri

SET 1 GCF-1 Vol#: 1
 
 

99N-4955 Amendment of Various Device Regulations

NCD 1 Vol#: 1

99P-4613 Revoke the Regulation That Approved Posilac

C 646 no signature Vol#: 35

C 647 Elise H. Vol#: 35

C 648 Nic Volk Vol#: 35

C 649 no signature Vol#: 35

C 650 no signature Vol#: 35

C 651 Joanne Court Vol#: 35

C 652 E. M. DuBois Vol#: 35

C 653 Ryan Vol#: 35

C 654 illegible Vol#: 35

C 655 Laila M. Vol#: 35

C 656 Rami Moussa Vol#: 35

C 657 Morton D. Vol#: 35

C 658 no signature Vol#: 35

C 659 Michelle Boonhower Vol#: 35

C 660 R. Vol#: 35

C 661 Becky Mello Vol#: 35

C 662 Tyler Chapman Vol#: 35

C 663 Ashleigh Vol#: 35

C 664 Marc Rickter Vol#: 35

C 665 Joannie Whitcomb Vol#: 35

C 666 Karen Hennig Vol#: 35

C 667 Justin Vol#: 35

C 668 Ralph Vol#: 35

C 669 no signature Vol#: 35

C 670 no signature Vol#: 35

C 671 Matt Slaney Vol#: 35

C 672 E. Vol#: 35

C 673 no signature Vol#: 35

C 674 Krist Vol#: 35

C 675 P. Vol#: 35

C 676 Sasha Dingle Vol#: 35

C 677 Lynette Noble Vol#: 35

C 678 no signature Vol#: 35

C 679 Kate Vol#: 35

C 680 J. Vol#: 35

C 681 Jeff Bresle Vol#: 35

C 682 Betsy Sharlach Vol#: 35

C 683 J. Foler Vol#: 35

C 684 Carol Baker Vol#: 35

C 685 J. Goeultt Vol#: 35

C 686 Sara Strope Vol#: 35

C 687 Kimberly Catton Vol#: 35

C 688 Steve Dingle Vol#: 35

C 689 Jared D. Ford Vol#: 35

C 690 Kristin Smith Vol#: 35

C 691 no signature Vol#: 35

C 692 Sarah Macnulty Vol#: 35

C 693 Christopher R. Corte Vol#: 35

C 694 Laurie B. Evan-Daly Vol#: 35

C 695 Amy Schwartz Vol#: 35

C 696 Clarissa Jocobs Vol#: 35

C 697 Jeffrey Vol#: 35

C 698 illegible Vol#: 35

C 699 Casey E. Sullivan Vol#: 35

C 700 illegible Vol#: 35

C 701 Ryan Foe Vol#: 35

C 702 Ellen Hansin Vol#: 35

C 703 D. B. Vol#: 35

C 704 C. Vol#: 35

C 705 Milan Vol#: 35

C 706 Carolyn B. Vol#: 35

C 707 Sara Pauhlak Vol#: 35

C 708 Gale Loveitt Vol#: 35

C 709 Cher Foley Vol#: 35

C 710 Pat Foley Vol#: 35

C 711 no signature Vol#: 35

C 712 no signature Vol#: 35

C 713 illegible Vol#: 35

C 714 Chris O. Vol#: 35

C 715 Sara Brown Vol#: 35

C 716 D. Storrs Vol#: 35

C 717 Nancy Ross Vol#: 35

C 718 Emily V. Vol#: 35

C 719 Noel Pullurty Vol#: 35

C 720 Lauren Sherman Vol#: 35

C 721 Jennifer Novosel Vol#: 35

C 722 Christopher Lann Vol#: 35

C 723 Emily Chambers Vol#: 35

C 724 Justin Vol#: 35

C 725 Jan Blake Vol#: 35

C 726 Abigail Blake Vol#: 35

C 727 no signature Vol#: 35

C 728 illegible Vol#: 35

C 729 Madison Heimert Vol#: 35

C 730 Scott Kisher Vol#: 35

C 731 Alisen Estey Vol#: 35

C 732 Nancy Thenaur Vol#: 35

C 733 Margaret Cole Vol#: 35

C 734 Merry Hutter Vol#: 35

C 735 Faith Alberti Vol#: 35

C 736 R. Imigk Vol#: 35

C 737 Sandra McNary Vol#: 35

C 738 Stephen A. Sayward, Jr. Vol#: 35

C 739 Catherine Galagis Vol#: 35

C 740 P. Hemmett Vol#: 35

C 741 R. Omigle Vol#: 35

C 742 illegible Vol#: 35

C 743 S. Abele Vol#: 35

C 744 Sophie Vol#: 35

C 745 Michelle Edwards Vol#: 35

C 746 R. D. Vol#: 35

C 747 Duncan Vol#: 35

C 748 Tracy Edwards Vol#: 35

C 749 Obesus Chunk Vol#: 35

C 750 Katherine Daly Vol#: 35

C 751 Tim Perkins Vol#: 35

C 752 Emily Schloff Vol#: 35

C 753 Mary Dahin Vol#: 35

C 754 Jerry Blais Vol#: 35

C 755 Charlotte & Thom Gosrich Vol#: 35

C 756 K. Van Der Weil Vol#: 35

C 757 J. M. C. Vol#: 35

C 758 Carlton Bates Vol#: 35

C 759 Ethel Ribinsky Vol#: 35

C 760 Laura Carter Vol#: 36

C 761 no signature Vol#: 36

C 762 D. D. Vol#: 36

C 763 Rachel Kremar Vol#: 36

C 764 Sarah White Vol#: 36

C 765 Cindy Barr Vol#: 36

C 766 Maris Cattie Vol#: 36

C 767 Marrinne Holec Vol#: 36

C 768 Andre Vol#: 36

C 769 Josh Aldrich Vol#: 36

C 770 Corinne C. O'Brien Vol#: 36

C 771 Suzanne A. Spring Vol#: 36

C 772 Kylie C Merck Forest & Farmland Center Vol#: 36

C 773 Pierre Hall Vol#: 36

C 774 Erin Ward Vol#: 36

C 775 Penelope Momaney Vol#: 36

C 776 Ben Russell Vol#: 36

C 777 Bess G. Vol#: 36

C 778 C. N. Vol#: 36

C 779 Leah Desroches Vol#: 36

C 780 Michelle Vol#: 36
 
 

00D-1341 Pilot Licensing Program for Immunization of Source Plasma

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1
 
 

00F-0786 Safe Use of Chlorine Dioxide

NCR 1 Vol#: 1
 
 

00H-1242 Civil Money Penalty;Laser Vision Centers Inc. et al

MO 2 LaserVision Centers Inc. Vol#: 1

MO 3 GCF-1 Vol#: 1

00N-1256 Over-the-Counter Drug Products;Public Hearing

CH 215 Patrick & Laura Fritz Vol#: 7

CH 216 Diane Robinette Vol#: 7

CH 217 Trudy M. Selig Vol#: 7

EC 383 Dr. james holcomb Vol#: 10

EC 384 Whitman Walker Clinic Vol#: 10

EC 385 resident, MUSC Vol#: 10

EC 386 Human Life Alliance Vol#: 10
 
 

00N-1380 Manipulation and Homologous Use in Spine and other Orthoped

NM 1 Vol#: 1

00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20

C 3 Nat'l Association of Pharmaceutical Mfrs Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 3046 Chad Rudaw Vol#: 134

C 3047 Peter Prady Vol#: 134

C 3048 Genevieve Mastinez Vol#: 134

C 3049 Carole Deeb Vol#: 134

C 3050 R. Lamiyan Vol#: 134

C 3051 Jan Belle Vol#: 134

C 3052 Barbara Williams Vol#: 134

C 3053 L. Mackool Vol#: 134

C 3054 Jerry Sinclair Vol#: 134

C 3055 Eric Henningsen Vol#: 134

C 3056 Mary Filosi Vol#: 134

C 3057 Virginia Romero Vol#: 134

C 3058 Sarah Robinson Vol#: 134

C 3059 J. Pakilla Vol#: 134

C 3060 Michael Lynch Vol#: 134

C 3061 Norma Martinez Vol#: 134

C 3062 Joanne S. Bell Vol#: 134

C 3063 Travis Nelsen Vol#: 134

C 3064 Onoria M. Albers Vol#: 134

C 3065 Sheila Parks Vol#: 134

C 3066 Doris Simon Vol#: 134

C 3067 A. Victoria Hunter Vol#: 134

C 3068 Aleen Starkweather Vol#: 134

C 3069 Marion Augustine Vol#: 134

C 3070 Rainbow R. MacDonald Vol#: 134

C 3071 Jill MacDonald Vol#: 134

C 3072 Flower MacDonald Vol#: 134

C 3073 Judith Rueston Vol#: 134

C 3074 Peter Fischer Vol#: 134

C 3075 Cam Jensen Vol#: 134

C 3076 Keith Kratzer Vol#: 134

C 3077 Irma Ross Vol#: 134

C 3078 Greg Powell Vol#: 134

C 3079 Dixie L. Lamantia Vol#: 134

C 3080 Vivica Ann Bell Vol#: 134

C 3081 Connie Akridge Vol#: 134

C 3082 Octavia Davis Vol#: 134

C 3083 Arthur Akridge Vol#: 134

C 3084 Betty Layman Vol#: 134

C 3085 Denise Reynolds Vol#: 134

C 3086 Jeff Cannon Vol#: 134

C 3087 Jody Kile Vol#: 134

C 3088 J. Kenyon Vol#: 134

C 3089 Denise Davis Vol#: 134

C 3090 Carol Segerstrom Vol#: 134

C 3091 Jim Stone Vol#: 134

C 3092 Nancy Vidal Vol#: 134

C 3093 Bruce Druliner Vol#: 134

C 3094 Cynthia Award Vol#: 134

C 3095 Marie Wingent Vol#: 135

C 3096 Carolyn Kellis Vol#: 135

C 3097 Laurie Simpson Vol#: 135

C 3098 Lisa F. Da'Oud Vol#: 135

C 3099 Jenna Lomazzo Vol#: 135

C 3100 Gisela S. Ray Vol#: 135

C 3101 Lucille S. Yaney Vol#: 135

C 3102 Barbara D. Wall Vol#: 135

C 3103 Gail Thompson Vol#: 135

C 3104 S. Kilbam Vol#: 135

C 3105 Linda Gianvoni Vol#: 135

C 3106 Donita K. Jelly Vol#: 135

C 3107 Barbara Fors Vol#: 135

C 3108 Amy Soucy Vol#: 135

C 3109 Laura J. Bryan Vol#: 135

C 3110 Matthew Jendian Vol#: 135

C 3111 Elizabeth A. DeBraber Vol#: 135

C 3112 David Florin Vol#: 135

C 3113 Francis Metraux Vol#: 135

C 3114 Phyllis & Raymond Ratte Vol#: 135

C 3115 Beverly Upham Vol#: 135

C 3116 Bernadette Hoyer Vol#: 135

C 3117 Joanne Maughlin Vol#: 135

C 3118 Elaine Funk Vol#: 135

C 3119 Alice King Parker Vol#: 135

C 3120 Lauri McKean Vol#: 135

C 3121 Dell Molfat Vol#: 135

C 3122 Polly L. Cook Vol#: 135

C 3123 Hildingers Vol#: 135

C 3124 Kathleen Dubel Vol#: 135

C 3125 Michael Sowiski Vol#: 135

C 3126 Sheila Zukowslay Vol#: 135

C 3127 Dana Gluckstein Vol#: 135

C 3128 C. Mikel Vol#: 135

C 3129 Barbara A. Davis Vol#: 135

C 3130 Heidi Hurwitz Vol#: 135

C 3131 Robin Martin Vol#: 135

C 3132 Jane Goldberg Vol#: 135

C 3133 Josiah Maskaleris Vol#: 135

C 3134 Adela Pisarevsky Vol#: 135

C 3135 Glen Risdon Vol#: 135

C 3136 Joyce & Ben Solomon Vol#: 135

C 3137 Debra L. Saye Vol#: 135

C 3138 Cecile Newcomb Vol#: 135

C 3139 Dr. Jane Henney Vol#: 135

C 3140 Oksana Marchenko Vol#: 135

C 3141 Karen Hillebrand Vol#: 135

C 3142 Erik Haag Vol#: 135

C 3143 Ken Roerden Vol#: 135

C 3144 Angeliaus Hutcherson Vol#: 135

C 3145 Mrs. D. Herberger Vol#: 135

C 3146 Virginia Mead & Jim Hoverman Vol#: 135

C 3147 Charlotte A. Battino Vol#: 135

C 3148 Amanda Allen Vol#: 135

C 3149 Sherri Baptist Vol#: 135

C 3150 Dr. Vivian Higgins Vol#: 135

C 3151 John Wevisch Vol#: 135

C 3152 Barbara Tayler Vol#: 135

C 3153 Wakuna MacDonald Vol#: 135

C 3154 Tammy Shaver Vol#: 135

C 3155 Spencer Fuelo Vol#: 135

C 3156 J. Johnson Vol#: 135

C 3157 F. Johnson Vol#: 135

C 3158 Stephanie Tullmann Vol#: 135

C 3159 Matthew Lauten Vol#: 135

C 3160 Charles Bunch & Carol Foltz Vol#: 135

C 3161 Dorothy Bolt Vol#: 135

C 3162 Priscilla Rose-Eckardt Vol#: 135

C 3163 Aaron Gouldthorpe Vol#: 135

C 3164 Mr & Mrs Rene G. Verdon Vol#: 135

C 3165 Michele Marco Vol#: 135

C 3166 Nancy deHoll Vol#: 135

C 3167 Sondra Blake Vol#: 135

C 3168 Debbie Captin Vol#: 135

C 3169 Dan Taylor Vol#: 135

C 3170 R. W. Gutt Vol#: 135

C 3171 Deanne Winegar Vol#: 135

C 3172 Sally Isaacs Vol#: 135

C 3173 James Johnson Vol#: 136

C 3174 Bonard & Mary Ellen Wilson Vol#: 136

C 3175 Theresa Houser Vol#: 136

C 3176 Shana Kent Vol#: 136

C 3177 Ann Peters Vol#: 136

C 3178 Gregory P. Mango Vol#: 136

C 3179 Susan Jacoby Vol#: 136

C 3180 Yehudit Lieberman Vol#: 136

C 3181 Darrell Randle Vol#: 136

C 3182 Lani Shipman Vol#: 136

C 3183 Jann Dudley Vol#: 136

C 3184 James Law Vol#: 136

C 3185 Suzanne Tate Vol#: 136

C 3186 Loren Reynolds Vol#: 136

C 3187 K. J. Karol Vol#: 136

C 3188 Gregory Taylor Vol#: 136

C 3189 Eileen Dolan Vol#: 136

C 3190 Charles Padnick Vol#: 136

C 3191 M. Spratt Vol#: 136

C 3192 Nina Ambrosino Vol#: 136

C 3193 Amy Rande Vol#: 136

C 3194 Brenda & Julian Bailey Vol#: 136

C 3195 Barbara Sheinmel Vol#: 136

C 3196 Sherylann Miller Vol#: 136

C 3197 Lita Kurth Vol#: 136

C 3198 Jennifer Karol Vol#: 136

C 3199 Richard W. Smith Vol#: 136

C 3200 M. Loftin Vol#: 136

C 3201 Nadia Khawam Vol#: 136

C 3202 June Humphreys Vol#: 136

C 3203 Joy Silva Vol#: 136

C 3204 Cristine Wellisch Vol#: 136

C 3205 Fred Conta Vol#: 136

C 3206 Sheri Martinez Vol#: 136

C 3207 James R. Schwander Vol#: 136

C 3208 Harriet N. Ottinger Vol#: 136

C 3209 Jeff Hirsch Vol#: 136

C 3210 Lois P. Carpenter Vol#: 136

C 3211 Annette Favrote Vol#: 136

C 3212 Annette Favrote Vol#: 136

C 3213 Seymour Koblin Vol#: 136

C 3214 Angela Mathews Vol#: 136

C 3215 Adaline Jurek Vol#: 136

C 3216 Nancy Sutor Vol#: 136

C 3217 Chloris M. Wendt Vol#: 136

C 3218 M. Collins Vol#: 136

C 3219 Vicki Crawford Vol#: 136

C 3220 Catherine A. Girard Vol#: 136

C 3221 Louis Seibert Vol#: 136

C 3222 Kristin Wood Vol#: 136

C 3223 A. Serwa Vol#: 136

C 3224 D. Dobkin Vol#: 136

C 3225 O. Akan Vol#: 136

C 3226 Mary Grigsby Vol#: 136

C 3227 Judith Bouche Vol#: 136

C 3228 Joanne Freedman Vitello Vol#: 136

C 3229 Lydia M. Davenport Vol#: 136

C 3230 Leslie McNamara Vol#: 136

C 3231 Morris Mele Vol#: 136

C 3232 Lillian Walston Vol#: 136

C 3233 Richard E. Peck Vol#: 136

C 3234 Laura Kurunski Vol#: 136

C 3235 Nadia Payne Vol#: 136

C 3236 Barbara Meyer Vol#: 136

C 3237 Christy Weckerun Vol#: 136

C 3238 Heather R. Hunter Vol#: 136

C 3239 Sadie W. Taylor Vol#: 136

C 3240 John Schoenwalter Vol#: 136

C 3241 John C. Mayeux Vol#: 136

C 3242 Frank Benestante Vol#: 136

C 3243 Michael Iannone Vol#: 136

C 3244 Dorothy Mack Vol#: 136

EMC 471 Joseph Dellinger Vol#: 135

EMC 472 Lisa Mallahan Vol#: 135

EMC 473 Jim Rich Vol#: 135

EMC 474 Chadi Kawkabani Vol#: 135

EMC 475 Heather Curry Vol#: 135

EMC 476 Michelle Indianer Vol#: 135

EMC 477 Jeanette Schuler Vol#: 135

EMC 478 Robin Eckhardt Vol#: 135

EMC 479 Judy Shull Vol#: 135

EMC 480 Laura Cristiano Vol#: 135

EMC 481 Lisa Kiesman Vol#: 135

EMC 482 Yuri Denson Vol#: 136

EMC 483 Alain M. Samoun Vol#: 136

EMC 484 Corrine Fierkens Vol#: 136

EMC 485 D. Hughes Vol#: 136

EMC 486 Susan Pitcarin Vol#: 136

EMC 487 Joseph T. Kenny, Jr. Vol#: 136

EMC 488 Amelia Hennighausen Vol#: 136

EMC 489 Carmen Breen Vol#: 136

EMC 490 Christie Walker Vol#: 136

EMC 491 Tim Manley Vol#: 136

EMC 492 Shay-Ann Heiser Vol#: 136

EMC 493 Melanee A. Loveless Vol#: 136

00V-1423 Laser Light Show

ACK 1 HFA-305 Vol#: 1