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DOCKETS ENTERED on November 6, 2000

TABLE OF CONTENTS

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95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1538 Electronic Records; Electronic Signatures, Validation *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt *
00P-1603 Rescind Any Contraindications For Use of Misoprostol In Preg *
77N-0085 Saccharin and Its Salts

C 24838 Dennis H. Miller Vol#:

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 80 Nutratech Inc Vol#: 54

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 396 HFS-456 to Twin Laboratories Inc Vol#: 11

LET 397 HFS-456 to Basic Research LLC dba Silver Vol#: 11

LET 398 HFS-456 to AMBI Inc Vol#: 11

LET 399 HFS-456 to Vitamin Shoppe Industries Inc Vol#: 11

LET 400 HFS-456 to Charman Pharmaceutical Inc Vol#: 11

LET 401 HFS-456 to Twin Laboraories Inc Vol#: 11

LET 402 HFS-456 to M K Health Food Distributors Vol#: 11

LET 403 HFS-456 to KT Natural Products Inc Vol#: 11

LET 404 HFS-456 to The Winning Combination Vol#: 11

LET 405 HFS-456 to Strictly Supplements Inc Vol#: 11

LET 406 HFS-456 to Novartis Consumer Health Inc Vol#: 11

LET 407 HFS-456 to Bogatin Law Firm (Cambridge Vol#: 11

LET 408 HFS-456 to Aura Shope Inc Vol#: 11

LET 409 HFS-456 to Nature's Herbs Vol#: 11

LET 410 HFS-456 to The Winning Combination Vol#: 11

LET 411 HFS-456 to Tabak's Health Products Vol#: 11

LET 412 HFS-456 to Zenith Goldline Pharmaceutica Vol#: 11

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

C 2473 Mary L. Garvey Vol#: 77

C 2474 Rev. Carmen Vale Ramos Vol#: 77

C 2475 Pam Hermsdorfer Vol#: 77

C 2476 Karen A. Thomas-Goto Vol#: 77

C 2477 Marilyn Evenson Vol#: 77

C 2478 Barbara Klonga Vol#: 77

C 2479 Julie DuShane Vol#: 77

C 2480 Margaret P. Toburen Vol#: 77

C 2481 Leslie Gougherty Vol#: 77

C 2482 Ms. Rae S. Sabella Vol#: 77

C 2483 Anna L. Moretto Vol#: 77

C 2484 Darlene Wheeler Vol#: 77

C 2485 Agnes Priddy Vol#: 77

C 2486 Vegetarian Society Vol#: 77

C 2487 Heidi Bond Vol#: 77

C 2488 Claire Martineau Vol#: 77

C 2489 Joyce N. Tichenor Vol#: 77

C 2490 Donna Campbell Vol#: 77

C 2491 Martha Bushnell, Ph.D. Vol#: 77

C 2492 Sonya Sokolow Vol#: 77

C 2493 Mary Ellen Cala Vol#: 77

C 2494 Jean Sutherland Vol#: 77

C 2495 Lyn Rosen-Springut Vol#: 77

C 2496 Elizabeth C. Lewis Vol#: 77

C 2497 Ellen J. Calnan Vol#: 77

C 2498 Shelly Kramer Vol#: 77

C 2499 Kay Smith & Charles Smith Vol#: 77

C 2500 Carol Lion Vol#: 77

C 2501 Larry Temin Vol#: 77

C 2502 Pat Curnow Vol#: 77

C 2503 Saxyn Piffath Vol#: 77

C 2504 Dori Villalon Vol#: 77

C 2505 Kelly Beard-Tittone Vol#: 77

C 2506 Rachel Thompson Vol#: 77

C 2507 Ruth Irvin Vol#: 77

C 2508 Anthony J. Dennis Vol#: 77

C 2509 Melanie Anne Jackson Vol#: 77

C 2510 Marie Reed Vol#: 77

C 2511 Dorothy Pierce Vol#: 77

C 2512 Ms. Carolyn M. Parkhurst Vol#: 77

C 2513 Angela Stewart, R.N., BSN Vol#: 77

C 2514 C. A. Richards Vol#: 77

C 2515 Kathryn Underwood-Zimmer Vol#: 77

C 2516 Rob Gonzalez Vol#: 77

C 2517 Christine Manno Vol#: 77

C 2518 Grace A. Golling Vol#: 78

C 2519 Pam Konyk Vol#: 78

C 2520 Kathryn Marie Pelkey Vol#: 78

C 2521 Marjorie Vol#: 78

C 2522 Brunilda Perez Vol#: 78

C 2523 Charles Betcher Vol#: 78

C 2524 Sandy H. Vol#: 78

C 2525 Bina Robinson Vol#: 78

C 2526 Jeanne Reed Vol#: 78

C 2527 Richard J. Mikita Vol#: 78

C 2528 Dolores Rodriguez Vol#: 78

C 2529 Margaret Shutt Vol#: 78

C 2530 Anita M. Adee Vol#: 78

C 2531 Shannon Reed Vol#: 78

C 2532 P. M. Putnam Vol#: 78

C 2533 Michael Briselli Vol#: 78

C 2534 Mrs. Katherine G. Bender Vol#: 78

C 2535 H. Frederick Gehrlach Vol#: 78

C 2536 Kimberly Walker Vol#: 78

C 2537 Amy H. Lutterloh Vol#: 78

C 2538 Virginia Schmit Vol#: 78

C 2539 Rachel Thompson Vol#: 78

C 2540 Connie Simpson Vol#: 78

C 2541 Sonya M. Garbutt Vol#: 78

C 2542 Deanne Foerster & Ramanand Puri Vol#: 78

C 2543 Dennis & Karle Haney Vol#: 78

EMC 174 Karen Weintraub, RN Vol#: 77

EMC 175 Robbi Courtaway Vol#: 77

EMC 176 Andrea Heaton Vol#: 77

EMC 177 Florentina La Barbera Vol#: 77

EMC 178 M. MacDowell Vol#: 77

EMC 179 M. Heinrich Vol#: 77

EMC 180 Midge Miller Vol#: 77

EMC 181 Kathleen Motz Vol#: 77

EMC 182 Lori Thielen Vol#: 77

EMC 183 Sherrill Durbin Vol#: 77

EMC 184 Joyce L. Friedman Vol#: 77

EMC 185 Mrs. Susan Gensinger Vol#: 77

EMC 186 Hrwglw Vol#: 77

EMC 187 Kristy Eggerton Vol#: 77

EMC 188 Melanie K. Roberts Vol#: 77

EMC 189 Shannon E. Hastings Vol#: 77

EMC 190 Carri L. Jean Vol#: 77

EMC 191 Tessie Dubois Vol#: 77

EMC 192 Rita Brinkman Vol#: 77

EMC 193 Ericka Wietecha Vol#: 77

EMC 194 Glenda Kallman Vol#: 77

EMC 195 N. Paula Lecht Vol#: 77

EMC 196 Dawn M. Pace Vol#: 77

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 15830 R. McHance Vol#: 466

C 15831 Rachel Boucher Vol#: 466

C 15832 Lawrence W. Ermey. Sr. Vol#: 466

C 15833 Margaret J. Keller Vol#: 466

C 15834 Linda Preuss Vol#: 466

C 15835 Audrey Armstrong Vol#: 466

C 15836 Joan Dy Vol#: 466

C 15837 Jerri Brandt Vol#: 466

C 15838 Bernard M. Bleeker Vol#: 466

C 15839 Shirley A. Larsen Vol#: 466

C 15840 Marina Markey Vol#: 466

C 15841 Y. DiMeglio Vol#: 466

C 15842 William Mordente Vol#: 466

C 15843 Pama Lee Hester Vol#: 466

C 15844 Dominique Baker Vol#: 466

C 15845 Cheryl Daymont Vol#: 466

C 15846 Marla Lindley Vol#: 466

C 15847 Berneta M. Kirchner Vol#: 466

C 15848 Mrs. Dorothy Handrick Vol#: 466

C 15849 Bernice E. Markus Vol#: 466

C 15850 Mary Sue Glorfield Vol#: 466

C 15851 Timothy L. Dehne Vol#: 466

C 15852 F. J. Davis Vol#: 466

C 15853 Nancy Meachum Vol#: 466

C 15854 Kathleen H. Hatfield Vol#: 466

C 15855 Mildred A. Brown Vol#: 466

C 15856 Mrs. Ruth H. Hoffmann Vol#: 466

C 15857 Mr & Mrs Ronald L. Wyatt Vol#: 466

C 15858 Margaretta McFeeters Vol#: 466

C 15859 Jenifer A. T. Taylor Vol#: 466

C 15860 Cynthia Kadohata Vol#: 466

C 15861 Linda Ewing Vol#: 466

C 15862 Carla & James Pelzl Vol#: 466

C 15863 Joanne K. Stone Vol#: 466

C 15864 John A. Knott Vol#: 466

C 15865 Mrs. Luella McGaer Vol#: 466

C 15866 Hilda Packard Vol#: 466

C 15867 Mrs. Robert G. Corley Vol#: 466

C 15868 Barbara A. Epidendio Vol#: 466

C 15869 William J. Sikorski Vol#: 466

C 15870 John Goin Vol#: 466

C 15871 Eileen Pesek Vol#: 466

C 15872 Robert D. Ritz Vol#: 466

C 15873 Gail Vaness Vol#: 466

C 15874 Johane Fortin Vol#: 466

C 15875 Dora Rose & Richard Gregory Howell Vol#: 466

C 15876 Nancy Mamen Vol#: 466

C 15877 John H. Fleming Vol#: 466

C 15878 Cecile A. Catania Vol#: 466

C 15879 Paul E. McIvor Vol#: 466

C 15880 David E. Gustafson Vol#: 466

C 15881 Stanley Clements Vol#: 466

C 15882 Judy L. Hall Vol#: 466

C 15883 Gary Hanson Vol#: 466

C 15884 Mary E. Collins Vol#: 466

C 15885 David C. Wilson Vol#: 466

C 15886 Katherine Knake Vol#: 466

C 15887 Janice E. Bradshaw Vol#: 466

C 15888 Violet Olsen Vol#: 466

C 15889 Peter Gerda & Ronald Kramer Vol#: 466

C 15890 Ms. Donna Whitlatch Vol#: 466

C 15891 Deborah R. Hollifield Vol#: 466

C 15892 Viltor Zaharchmento Vol#: 466

C 15893 Chris Loucka Vol#: 466

C 15894 Howard & Margaret Bray Vol#: 466

C 15895 Elly E. Quici Vol#: 466

C 15896 Katherine Fitzpatrick Vol#: 466

C 15897 Ronda Corn Vol#: 466

C 15898 Mary Lou Coogan Vol#: 466

C 15899 Patricia Jean Ceglia Vol#: 466

C 15900 Bob Biles Vol#: 466

C 15901 Patricia Ferguson Vol#: 466

C 15902 Susan Shunway Vol#: 466

C 15903 Jennifer Reeg Vol#: 466

C 15904 Mrs. Mary Hanson Vol#: 466

C 15905 Julie T. Charland Vol#: 466

C 15906 Paul Daniel Kreutz Vol#: 466

C 15907 Maureen Nest Vol#: 466

C 15908 Roma R. Rentz Vol#: 466

C 15909 Jennifer Grant & Gene Hubbard Vol#: 466

C 15910 Krista Lamoreaux Vol#: 466

C 15911 Alma Jean Berg Vol#: 466

C 15912 Luella Iva Goeman Vol#: 466

C 15913 Julia M. Rushing Vol#: 466

C 15914 Richard & Eileen Haberstroh Vol#: 466

C 15915 Lee Moen Vol#: 466

C 15916 Janice Brown Vol#: 466

C 15917 Shirley Ann Clark Vol#: 466

C 15918 Rebecca Kay Segur Vol#: 466

C 15919 Barbara Schlein Vol#: 467

C 15920 Wynter Snow Vol#: 467

C 15921 Walter & Karen Kieckhefer Vol#: 467

C 15922 Healthcare Research, Ltd. Vol#: 467

C 15923 Mrs. M. Bokleman Vol#: 467

C 15924 Margaret Klebanoff + 4 signatures Vol#: 467

C 15925 Peggy Yarrow Vol#: 467

C 15926 Daniel Warren + 5 signatures Vol#: 467

C 15927 Betty Brown Vol#: 467

C 15928 S. Helnick Vol#: 467

C 15929 Virgis & Judith Franks Vol#: 467

C 15930 Mrs. Alois Ischampl Vol#: 467

C 15931 Susan Rose Vol#: 467

C 15932 Tommie Cox Vol#: 467

C 15933 Dana Darlene Chitwood Vol#: 467

C 15934 Susan Toal Vol#: 467

C 15935 Sueanne Bell Vol#: 467

C 15936 Betty Evans Vol#: 467

C 15937 Stuart Gummer Vol#: 467

C 15938 Janet Gautier Vol#: 467

C 15939 Wendy Riopel Vol#: 467

C 15940 Anne M. Garcia Vol#: 467

C 15941 Jane Picardi Vol#: 467

C 15942 Florence Naylor Vol#: 467

C 15943 Sophia & Mael Melvin Vol#: 467

C 15944 Shirley Moreno Vol#: 467

C 15945 Dick & Betsy Kerr Vol#: 467

C 15946 Phyllis M. Pekrul Vol#: 467

C 15947 Fran & Fred Malcher, Sr. Vol#: 467

C 15948 Jane Sigsworth Vol#: 467

C 15949 William & Pauline Ornberg Vol#: 467

C 15950 Michael & Marti Hanson Vol#: 467

C 15951 James & Marie Foose Vol#: 467

C 15952 Joseph Q. Lopez Vol#: 467

C 15953 Judy Dewald Vol#: 467

C 15954 Tommy Ponce Vol#: 467

C 15955 Benne L. Elmore Vol#: 467

C 15956 Dean Hutchins Vol#: 467

C 15957 Gerry Victor Vol#: 467

C 15958 June Beard Vol#: 467

C 15959 Barbara McBride Vol#: 467

C 15960 James Leslie Hall Vol#: 467

C 15961 Corine Crea Vol#: 467

C 15962 Belle Magola-Imig Vol#: 467

C 15963 Eugene Vernon Gilland Vol#: 467

C 15964 Michelle Fischer Vol#: 467

C 15965 Anita Young Vol#: 467

C 15966 Anne K. Burkhart Vol#: 467

C 15967 Shirley Hambee Vol#: 467

C 15968 Betsy Wild Vol#: 467

C 15969 Christine Beal-Kaplan Vol#: 467

C 15970 Beverly Sines Vol#: 467

C 15971 James A. Wise Vol#: 467

C 15972 Jeff & Vicki Nace Vol#: 467

EMC 3230 Sharon Barnett Vol#: 466

EMC 3231 Tristen Tuckfield Vol#: 466

EMC 3232 Kel Pickens Vol#: 466

EMC 3233 Kathleen Robinson Vol#: 466

EMC 3234 Carol Slechta Vol#: 466

EMC 3235 Mara Ribbin Vol#: 466

EMC 3236 Olivia Zivney Vol#: 466

EMC 3237 Lewis Kawecki Vol#: 466

EMC 3238 Stephen Kovacs Vol#: 466

EMC 3239 Michael Polidori Vol#: 467

EMC 3240 Johnathan Janssen Vol#: 467

EMC 3241 Hillary Stainthorpe Vol#: 467

EMC 3242 Jane Gerald Vol#: 467

EMC 3243 Jeanine Alcocer Vol#: 467

EMC 3244 Margaret Clay Vol#: 467

EMC 3245 Geraldine Mellon Vol#: 467

EMC 3246 Carla Keirstead Vol#: 467

EMC 3247 no signature Vol#: 467

EMC 3248 Barbara L. Wood Vol#: 467

EMC 3249 Avi Sharoni Vol#: 467

EMC 3250 Tom Pendleton Vol#: 467

EMC 3251 Rajiv Shah Vol#: 467

EMC 3252 Lydia LaFleur Vol#: 467

EMC 3253 Heather Fayhee Vol#: 467

EMC 3254 Kitty Giannini Vol#: 467

EMC 3255 Bill Snover Vol#: 467

EMC 3256 Rex Bavousett Vol#: 467

EMC 3257 Mary Cuchna Vol#: 467

EMC 3258 John Hopwood Vol#: 467

EMC 3259 Laura Denoncourt Vol#: 467

EMC 3260 Martin Walter Vol#: 467

EMC 3261 Michael Ellis Vol#: 467

EMC 3262 Leigh Goldstein Vol#:

EMC 3263 Leigh Goldstein Vol#: 467

EMC 3264 Denise Trimble Vol#: 467

EMC 3265 Robert Bennett Vol#: 467

EMC 3266 Rodger A. Clarke Vol#: 467

EMC 3267 Michele E. Hannum Vol#: 467

00D-1538 Electronic Records; Electronic Signatures, Validation

EMC 1 CHPA Vol#: 1

LET 1 CHPA Vol#: 1

MM 1 HFC-240 & VeriSign Inc Vol#: 1

MM 2 HFC-240 & ISPE, GAMP, PDA (2/25/00) Vol#: 1

MM 3 HFC-240 & Andersen Consulting (3/15/00) Vol#: 1

MM 4 HFC-240 & American Society for Quality Vol#: 1

MM 5 HFC-240 & Industry Coalition (9/13/00) Vol#: 1

RPT 1 CHPA - Industry Coalition Paper Vol#: 1

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

EMC 1 CHPA Vol#: 1

LET 1 CHPA Vol#: 1

MM 1 HFC-240 & VeriSign Inc Vol#: 1

MM 2 HFC-240 & ISPE, GAMP, PDA (2/25/00) Vol#: 1

MM 3 HFC-240 & Andersen Consulting (3/15/00) Vol#: 1

MM 4 HFC-240 & American Society for Quality Vol#: 1

MM 5 HFC-240 & Industry Coalition (9/13/00) Vol#: 1

RPT 1 CHPA - Industry Coalition Paper Vol#: 1

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

EMC 1 CHPA Vol#: 1

LET 1 CHPA Vol#: 1

MM 1 HFC-240 & VeriSign Inc Vol#: 1

MM 2 HFC-240 & ISPE, GAMP, PDA (2/25/00) Vol#: 1

MM 3 HFC-240 & Andersen Consulting (3/15/00) Vol#: 1

MM 4 HFC-240 & American Society for Quality Vol#: 1

MM 5 HFC-240 & Industry Coalition (9/13/00) Vol#: 1

RPT 1 CHPA - Industry Coalition Paper Vol#: 1

00D-1541 Electronic Signatures: Audit Trails

EMC 1 CHPA Vol#: 1

LET 1 CHPA Vol#: 1

MM 1 HFC-240 & VeriSign Inc Vol#: 1

MM 2 HFC-240 & ISPE, GAMP, PDA (2/25/00) Vol#: 1

MM 3 HFC-240 & Andersen Consulting (3/15/00) Vol#: 1

MM 4 HFC-240 & American Society for Quality Vol#: 1

MM 5 HFC-240 & Industry Coalition (9/13/00) Vol#: 1

RPT 1 CHPA - Industry Coalition Paper Vol#: 1

00D-1542 Electronic Signatures: Time Stamps

EMC 1 CHPA Vol#: 1

LET 1 CHPA Vol#: 1

MM 1 HFC-240 & VeriSign Inc Vol#: 1

MM 2 HFC-240 & ISPE, GAMP, PDA (2/25/00) Vol#: 1

MM 3 HFC-240 & Andersen Consulting (3/15/00) Vol#: 1

MM 4 HFC-240 & American Society for Quality Vol#: 1

MM 5 HFC-240 & Industry Coalition (9/13/00) Vol#: 1

RPT 1 CHPA - Industry Coalition Paper Vol#: 1

00D-1543 Electronic Signatures: Glossary of Terms

EMC 1 CHPA Vol#: 1

LET 1 CHPA Vol#: 1

MM 1 HFC-240 & VeriSign Inc Vol#: 1

MM 2 HFC-240 & ISPE, GAMP, PDA (2/25/00) Vol#: 1

MM 3 HFC-240 & Andersen Consulting (3/15/00) Vol#: 1

MM 4 HFC-240 & American Society for Quality Vol#: 1

MM 5 HFC-240 & Industry Coalition (9/13/00) Vol#: 1

RPT 1 CHPA - Industry Coalition Paper Vol#: 1

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

MO 6 Laser Vision Centers Inc. Vol#: 1

MO 7 Laser Vision Centers Inc. Vol#: 1

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

C 7338 Donna Palmer Vol#: 321

C 7339 Theresa Carbry Vol#: 321

C 7340 Pat des Chene, DVM Vol#: 321

C 7341 Ann Golden Vol#: 321

C 7342 Jay Wells Vol#: 321

C 7343 Stacy Tilmann Vol#: 321

C 7344 Rosamond March Vol#: 321

C 7345 Anthony & Susan Trujillo Vol#: 321

C 7346 Celinda Miller Vol#: 321

C 7347 Cynthia Taber Vol#: 321

C 7348 Eri Myers Vol#: 321

C 7349 Ben Hills Vol#: 321

C 7350 Jordan Miller Vol#: 321

C 7351 Kate Single Vol#: 322

C 7352 Sharon Herberk Vol#: 322

C 7353 Kurt Johnson Vol#: 322

C 7354 Kathy Kinzfogl Vol#: 322

C 7355 Apryli Burkhart Vol#: 322

C 7356 Orlin H Meyer Vol#: 322

C 7357 Trevor J Davis Vol#: 322

C 7358 Michelle Calascibetta Vol#: 322

C 7359 Theo Brakebill Vol#: 322

C 7360 Trisha Lovgren Vol#: 322

C 7361 Mark Hamilton Vol#: 322

C 7362 Jeff Howard Vol#: 322

00P-1602 Remove Unapproved Children's Fluoride Supplements from Mkt

ACK 1 HFA-305 Vol#: 1

CP 1 New Jersey General Assembly Vol#: 1

00P-1603 Rescind Any Contraindications For Use of Misoprostol In Preg

ACK 1 HFA-305 Vol#: 1

CP 1 American College of Obstetricians & Gyne Vol#: 1

00V-1605 Laser Light Show

VAR 1 Sam's Town Hotel and Casino Vol#: 1

00V-1606

VAR 1 U.S. Space and Rocket Center Vol#: 1