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 27, 2000

Table of Contents

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94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97N-0436 Methods informing consumers of contents of bottle water *
99P-2630 Establish a Daily Value for "added sugars" *
99P-4613 Revoke the Regulation That Approved Posilac *
00D-0805 Requirements for Emergency Research *
00D-0835 Conjugated Estrogens,USP-LC-MS Method for Qualitative Chemic *
00D-1277 Fumonisin Levels in Human Foods and Animal Feed *
00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment *
00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers *
00N-1034 Cost Assessment of Medical Device Tracking *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
00P-1225 ANADA Suitability for Ivermectin Liquid for Horses *
00P-1325 Declare Tylenol Arthritis Extended Relief Misbranded *
00V-1430 Laser Light Show*

94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 2178 Peter Perthou Vol#: 62

C 2179 Judge Henry X. Dietch Vol#: 62

C 2180 Department of Agriculture Vol#: 62

EMC 480 Pam Williams Vol#: 62

EMC 481 Paul Dunlap Vol#: 62

EMC 482 Domigene Yellets Vol#: 62

LET 15 Judge Henry X. Dietch Vol#: 62

LET 16 Judge Henry X. Dietch Vol#: 62

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

C 295 Kenneth John Gilmour Vol#: 4

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

RPT 72 Audax Inc Pharmaceuticals Vol#: 41

RPT 73 Humanetics Corporation Vol#: 46

96M-0311 Guideline on Infectious Disease Issues in Xenotransplantatio

C 165 Genzyme Corporation and Diacrin, Inc. Vol#: 20

C 166 Nextran, Inc. Vol#: 20

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

C 204 Judith Cammack Vol#: 7

C 205 Tom & Celia Sonnabend Vol#: 7

C 206 Anna E. Platz Vol#: 7

C 207 Phyllis J. Love Vol#: 7

C 208 June Chiavard Vol#: 7

98H-0991 Civil Money Penalties; Kevin Van Zee,d/b/a Julesburg Family

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0753 Civil Money Penalties;Charles Hart & Jack Parker,d/b/a Villa

CR 1 GCF-1 Vol#: 1

99H-0983 Civil Money Penalties;Kmart Corp,d/b/a Kmart Store #3310

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0984 Civil Money Penalties;Pantry Markets Ltd,d/b/a The Pantry

LET 2 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

99H-0986 Civil Money Penalties;Charles Harrington,d/b/a 7-Eleven

LET 3 Office of Tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

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

C 14200 Hilda M. Diaz Vol#: 431

C 14201 Robert Speakman Vol#: 431

C 14202 Janet Taylor Levin Vol#: 431

C 14203 B. Asmussen Vol#: 431

C 14204 Judith A. Johnson Vol#: 431

C 14205 Francis E. DeDoe Vol#: 431

C 14206 Laura Kalman Vol#: 431

C 14207 Beverly Phillips Vol#: 431

C 14208 George E. Coly Vol#: 431

C 14209 Marcella J. Tweson Vol#: 431

C 14210 Patricia Summers & Family Vol#: 431

C 14211 Linda Kirshy Vol#: 431

C 14212 Annetta H. Weinbordt Vol#: 431

C 14213 Pat Grizzel Vol#: 431

C 14214 Lauren Munach Vol#: 431

C 14215 Martha Brower Vol#: 431

C 14216 Joyce S. Smith Vol#: 431

C 14217 Lori A. Tanger Vol#: 431

C 14218 Colleen R. Speed Vol#: 431

C 14219 Cameron Lea Gates Mann Vol#: 431

C 14220 Genie Gray Vol#: 431

C 14221 Jenny Lind Vol#: 431

C 14222 Rose Najia Vol#: 431

C 14223 Grace Sapia Vol#: 431

C 14224 Laurie Simpson Vol#: 431

C 14225 Roselyn Kelly Vol#: 431

C 14226 Eamon Brennais Vol#: 431

C 14227 Janet Espinoza Vol#: 431

C 14228 Tamara Klindt Vol#: 431

C 14229 Marie Winger Vol#: 431

C 14230 Laurie Simpson Vol#: 431

C 14231 Carolyn Kellis Vol#: 431

C 14232 John F. Kohler Vol#: 431

C 14233 Karen Croxton Vol#: 431

C 14234 Dr. Doug & Linda Baker Vol#: 431

C 14235 Lynda Aschauer Vol#: 431

C 14236 Anne Buggy Vol#: 431

C 14237 American Society for Microbiology Vol#: 432

C 14238 Andrea Jennison Vol#: 432

C 14239 Kim Crabill + 13 signatures Vol#: 432

C 14240 Nancy Thomson Vol#: 432

C 14241 Holle Kathenes Vol#: 432

C 14242 Debra E. van Wandelen Vol#: 432

C 14243 Victoria Shnayer Vol#: 432

C 14244 Glen Risdon Vol#: 432

C 14245 Amy Iwata Vol#: 432

C 14246 International Food Additives Council Vol#: 432

C 14247 Alexandra Schabel Vol#: 432

C 14248 Cathy O'Leary Vol#: 432

C 14249 Jennifer Rhea Vol#: 432

C 14250 Jeri Midgley Vol#: 432

C 14251 David W. Huber Vol#: 432

C 14252 Robin Cosby Vol#: 432

C 14253 Stella McCormick Vol#: 432

C 14254 Cynthia Hendry Vol#: 432

C 14255 Linda F. Shepard Vol#: 432

C 14256 Geraldine Macomber Vol#: 432

C 14257 Karen R. Olson Vol#: 432

C 14258 Anna Marie Rider Vol#: 432

C 14259 Dorothy F. Horton Vol#: 432

C 14260 Christine Anderson Vol#: 432

C 14261 Harry Mashtare Vol#: 432

C 14262 Janet Grecsek Vol#: 432

C 14263 Wes Duren Vol#: 432

C 14264 Judith Leifer-Bentz Vol#: 432

C 14265 Donna Middlebrook Vol#: 432

C 14266 Mrs. Billy Guy Vol#: 432

C 14267 Helen Lorinc Vol#: 432

C 14268 Patricia A. Walsh Vol#: 432

C 14269 Mark & Alice Feemster Vol#: 432

C 14270 Connie Earhart Vol#: 432

C 14271 Aimee Gaffner Vol#: 432

C 14272 Peggy Ann Marion Vol#: 432

C 14273 Lois Ternes Vol#: 432

C 14274 Irmgard Haskins Vol#: 432

C 14275 Bernice Rittner Vol#: 432

C 14276 Miss Toni West Vol#: 432

C 14277 Debra Grabek Vol#: 432

C 14278 Dawn Bahr Vol#: 432

C 14279 Glenda J. Sanders Vol#: 432

C 14280 Anthony Wayne Johnson Vol#: 432

C 14281 Guy Merck Vol#: 432

C 14282 Richard Knaub Vol#: 432

C 14283 Lou Fassi Vol#: 432

C 14284 Frances Cooper Vol#: 432

C 14285 Dorothy C. Girard Vol#: 432

C 14286 Jane Sinsky Vol#: 432

C 14287 Edwin Schlapfer Vol#: 432

C 14288 Mr & Mrs Anthony Dezort Vol#: 432

C 14289 Beth Martel Vol#: 432

C 14290 K. Stephensen Vol#: 432

C 14291 Lori Kuebler Vol#: 432

C 14292 Sara Batchelder Vol#: 432

C 14293 Geraldine Roberts Vol#: 432

C 14294 Richard Hermann Schmidt Vol#: 432

C 14295 Leslie Pierport Vol#: 432

C 14296 Margaret A. Henkels Vol#: 432

C 14297 Shirley Lussi Vol#: 432

C 14298 J. T. & Joanie Vaughn Vol#: 432

C 14299 Elinore Gordon Vol#: 432

C 14300 Mary Stevenson Vol#: 432

C 14301 J. H. Criner Vol#: 432

C 14302 Anita Gray Vol#: 432

C 14303 Deolinda Rhoads Vol#: 432

C 14304 Shelly M. Davidson Vol#: 432

C 14305 Luciwdad Lee Lipton Vol#: 432

C 14306 Louise A. Clay Vol#: 432

C 14307 Linda F. Long Vol#: 432

C 14308 Ron Berger Vol#: 432

C 14309 Randolph Clever Vol#: 432

C 14310 Lynn Marie Linden Vol#: 432

C 14311 William A. Setterlund Vol#: 432

C 14312 Shawna Harper Vol#: 432

EMC 2967 Diana E. Smith Vol#: 432

EMC 2968 RikkyLoo Vol#: 432

EMC 2969 Alain M. Samoun Vol#: 432

EMC 2970 Karen Isaacson Vol#: 432

EMC 2971 R. Brown Vol#: 432

EMC 2972 Shay-Ann Heiser Vol#: 432

EMC 2973 Melanie Loveless Vol#: 432

EMC 2974 Darryl Jordan Vol#: 432

EMC 2975 Alexis Page Vol#: 432

EMC 2976 Jennifer Pence Vol#: 432

EMC 2977 Jim Weber Vol#: 432

EMC 2978 Bruk Miller Vol#: 432

EMC 2979 John Hamilton Vol#: 432

EMC 2980 Donald Yee Vol#: 432

EMC 2981 Robin Mencher Vol#: 432

EMC 2982 Rachel Cort Vol#: 432

EMC 2983 Debra Fenzel-Alexander Vol#: 432

EMC 2984 Bonnie Caruthers Vol#: 432

EMC 2985 Sandra Garrett Vol#: 432

EMC 2986 Daniel Read Vol#: 432

EMC 2987 Charon Tyrrell Vol#: 432

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

C 120 Cindy Heckscher Vol#: 7

C 121 John F. Honek Vol#: 7

C 122 Cooper Clinic Vol#: 7

C 123 Yale University Vol#: 7

C 124 Chippewa County Department of Public Hlt Vol#: 7

EC 9 Mr. alain samoun Vol#: 7

EC 10 Mrs. wendy mccarthy Vol#: 7

EC 11 Mr. Douglas Hornyak Vol#: 7

EMC 3 Iowa Health System Vol#: 7

99P-4613 Revoke the Regulation That Approved Posilac

C 851 illegible Vol#: 37

C 852 Courtney Nutting Vol#: 37

C 853 Doug Lyons Vol#: 37

C 854 Elizabeth Vol#: 37

C 855 J. Breer Vol#: 37

C 856 Dana Vol#: 37

C 857 Adam Tripi Vol#: 37

C 858 Denise Bolter Vol#: 37

C 859 no signature Vol#: 37

C 860 Annie Boutin Vol#: 37

C 861 Stephen Cheever Vol#: 37

C 862 Rose Graves Vol#: 37

C 863 Emily Alexander Vol#: 37

C 864 illegible Vol#: 37

C 865 Sam Vol#: 37

C 866 Janet Baker Vol#: 37

C 867 N. Colvin Vol#: 37

C 868 David Morenay Vol#: 37

C 869 Richard Warren Vol#: 37

C 870 illegible Vol#: 37

C 871 Shelley B. Cohen Vol#: 37

C 872 Jonathan Keenie Vol#: 37

C 873 illegible Vol#: 37

C 874 no signature Vol#: 37

C 875 C. Vol#: 37

C 876 Joan Beard Vol#: 37

C 877 P. J. Viger Vol#: 37

C 878 Diane Fisher Vol#: 37

C 879 Veronica Galaida Vol#: 37

C 880 Bradley Staples Vol#: 37

C 881 J. G. Isaselle Vol#: 37

C 882 Paula Kolb Vol#: 37

C 883 Tessa Vol#: 37

C 884 no signature Vol#: 37

C 885 no signature Vol#: 37

C 886 Veronica Galuida Vol#: 37

C 887 Amber Hayden Vol#: 37

C 888 M. Vol#: 37

C 889 Mike Wahl Vol#: 37

C 890 no signature Vol#: 37

C 891 Sherry Merrick, R.N. Vol#: 37

C 892 Paul Vaczy Vol#: 37

C 893 Jen Conetta Vol#: 37

C 894 Amber Morehouse Vol#: 37

C 895 Jayne B. Vol#: 37

C 896 illegible Vol#: 37

C 897 Maureen O'Hara Vol#: 37

C 898 Jeff Ritcline Vol#: 37

C 899 illegible Vol#: 37

C 900 Olivia Merithan Vol#: 37

C 901 no signature Vol#: 37

C 902 no signature Vol#: 37

C 903 Shelley Barsaute Cohen Vol#: 37

C 904 Jim Haignay Vol#: 37

C 905 no signature Vol#: 37

C 906 Catherine Lachence Vol#: 37

C 907 Jefree Kaufman Vol#: 37

C 908 Alida Dyer Vol#: 37

C 909 Gail Kipp Vol#: 37

C 910 Lauren Golten Vol#: 37

C 911 no signature Vol#: 37

C 912 K. Spies Vol#: 37

C 913 M. Vol#: 37

C 914 Dana Rackley Vol#: 37

C 915 Nathan H. Vol#: 37

C 916 Deb Garsus Vol#: 37

C 917 G. Y. Vol#: 37

C 918 Jana Marshall Vol#: 37

C 919 Brad Eigel Vol#: 37

C 920 Kristina Macy Vol#: 37

C 921 John Frion Vol#: 37

C 922 Cain C. Vol#: 37

C 923 Amy Marine Vol#: 37

C 924 Bruce Jost Vol#: 37

C 925 Gabriela Garza Vol#: 37

C 926 Loretta Sandmal Vol#: 37

C 927 Mott K. Vol#: 37

C 928 Christy Sipsy Vol#: 37

C 929 R. Vol#: 37

C 930 Mary Hergar Vol#: 37

C 931 Kinston Cole Vol#: 37

00D-0805 Requirements for Emergency Research

C 7 Indian Health Service Vol#: 5

00D-0835 Conjugated Estrogens,USP-LC-MS Method for Qualitative Chemic

C 1 Jerussi Consulting, Inc. Vol#: 1

00D-1277 Fumonisin Levels in Human Foods and Animal Feed

C 1 Frito-Lay, Inc. Vol#: 1

00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment

C 1 The University of York Vol#: 1

00D-1350 Combined Oral Contraceptives/Labeling/Healthcare Providers

C 1 Schering Vol#: 1

00N-1034 Cost Assessment of Medical Device Tracking

C 1 Ross Products Division of Abbott Lab Vol#: 1

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

C 1 Nisbet Oyster Co., Inc. Vol#: 1

C 2 Andrew T. Weil M.D. Vol#: 1

EC 4 N.A. Vol#: 1

EC 5 Orange Coast Foods, Inc. Vol#: 1

00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs

C 3 Brent Jones Vol#: 1

EXT 1 International Academy of Compounding Phm Vol#: 1

00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair

C 1 Capital Neurosurgery, Inc. Vol#: 1

C 2 Spinal Surgery, Spinal Deformity & Gen Vol#: 1

C 3 American Association of Tissue Banks Vol#: 1

C 4 JFK Neuroscience Center Vol#: 1

C 5 Arthroscopy Association of North America Vol#: 1

C 6 Midwest neurosurgery Associates, P.C. Vol#: 1

C 7 Neurosurgery, Inc. Vol#: 1

C 8 Spine Care Medical Group Vol#: 1

C 9 Emory Healthcare, The Emory Clinic, Inc. Vol#: 1

C 10 Tallahassee Neurological Clinic, P.A. Vol#: 1

C 11 Joplin Neurosurgical Associates, Inc. Vol#: 1

C 12 Shriners Hospitals for Children Vol#: 1

00P-1210 Restrict Sale of Coal Tar-Containing Products

C 2 Occupational Knowledge International Vol#: 1

00P-1225 ANADA Suitability for Ivermectin Liquid for Horses

PDN 1 HFV-100 to Equi Aid Products, Inc. Vol#: 1

00P-1325 Declare Tylenol Arthritis Extended Relief Misbranded

C 1 Whitehall Robins Vol#: 1

00V-1430 Laser Light Show

ACK 1 HFA-305 Vol#: 1