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 May 9, 2001

TABLE OF CONTENTS

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97N-484P Current Good Tissue Practice for Mfrs. of Human Cellular *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98N-1038 Irradiation in the production, processing, &handling of food *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
99P-5106 Identify Sources of Natural Flavorings *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1662 Use of Xenotransplantation Products in Humans *
00D-1681 Potassium Iodide as a Thyroid Blocking Agent *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled *
01D-0044 Clinical Laboratory Improvement Amendments of 1988 *
01E-0225 Patent Term Extension Application, CANCIDAS No. 5,514,650
01E-0229 Patent Term Extension Application, PAYLEAN No. 4,690,951
01P-0228 Clarify the"intended use of" regulated/labeling products *

96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency

NAL 1 Vol#: 1

S 1 SUPPORTING STATEMEMT Vol#: 1

96V-0088 Variance for Laser Light Show

EXP 1 East Coast Control Systems, Inc. Vol#: 1

97N-484P Current Good Tissue Practice for Mfrs. of Human Cellular

C 23 Abbott Laboratories Vol#: 5

C 24 American Assoc of Blood Banks (AABB) Vol#: 5

C 25 American Academy of Ophthalmology Vol#: 5

C 26 Amer Soc For Reproductive Medicine Vol#: 5

C 27 King & Spalding Vol#: 5

C 28 American Association of Tissue Banks Vol#: 5

C 29 American College of Obstetricians & Gyn Vol#: 5

C 30 College of American Pathologists Vol#: 5

C 31 Amer Acad of Orthopaedic Surgeons Vol#: 5

C 32 Clearant Vol#: 5

C 33 Eye Bank Association Of America Vol#: 6

C 34 World Marrow Donor Association (WMDA) Vol#: 5

97P-0441 Regulatory Status of Cholestin red yeast rice

EMC 1 James & Marilyn Faulconer Vol#: 15

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 6830 Green Turtle Bay Vitamin Co Inc Vol#: 53

LET 6831 Green Turtle Bay Vitamin Co Inc Vol#: 53

LET 6832 Herb Pharm Vol#: 53

LET 6833 Herb Pharm Vol#: 53

LET 6834 Herb Pharm Vol#: 53

LET 6835 Herb Pharm Vol#: 53

LET 6836 Herb Pharm Vol#: 53

LET 6837 Herb Pharm Vol#: 53

LET 6838 Herb Pharm Vol#: 53

LET 6839 Herb Pharm Vol#: 53

LET 6840 Herb Pharm Vol#: 53

LET 6841 Herb Pharm Vol#: 53

LET 6842 Herb Pharm Vol#: 53

LET 6843 Country Life Vol#: 53

LET 6844 Country Life Vol#: 53

LET 6845 NOW Foods Vol#: 53

LET 6846 USANA Health Sciences Inc Vol#: 53

LET 6847 Country Life Vol#: 53

LET 6848 Country Life Vol#: 53

LET 6849 Country Life Vol#: 53

LET 6850 Herb Pharm Vol#: 53

LET 6851 Country Life Vol#: 53

LET 6852 Pro Pac Labs Vol#: 53

LET 6853 Chattem Inc Vol#: 53

LET 6854 Source Naturals Vol#: 53

LET 6855 Country Life Vol#: 53

LET 6856 Procter & Gamble Company Vol#: 53

LET 6857 Biocodex Inc Vol#: 53

LET 6858 MediHerb PTY LTD Vol#: 53

LET 6859 MediHerb PTY LTD Vol#: 53

LET 6860 MediHerb PTY LTD Vol#: 53

LET 6861 MediHerb PTY LTD Vol#: 53

LET 6862 MediHerb PTY LTD Vol#: 53

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LET 6864 MediHerb PTY LTD Vol#: 53

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LET 6980 MediHerb PTY LTD Vol#: 53

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LET 6989 MediHerb PTY LTD Vol#: 53

LET 6990 MediHerb PTY LTD Vol#: 53

LET 6991 MediHerb PTY LTD Vol#: 53

LET 6992 MediHerb PTY LTD Vol#: 53

LET 6993 MediHerb PTY LTD Vol#: 53

LET 6994 MediHerb PTY LTD Vol#: 53

LET 6995 MediHerb PTY LTD Vol#: 53

LET 6996 MediHerb PTY LTD Vol#: 53

LET 6997 MediHerb PTY LTD Vol#: 53

LET 6998 MediHerb PTY LTD Vol#: 53

LET 6999 MediHerb PTY LTD Vol#: 53

LET 7000 MediHerb PTY LTD Vol#: 53

LET 7001 NOW Foods Vol#: 53

97V-0231 Laser light show

EXP 1 Paramount Event Services Vol#: 1

98N-0170 Manufacturer Reporting, Importer Reporting, User Facility

NFR 3 Vol#: 1

98N-1038 Irradiation in the production, processing, &handling of food

C 5278 Paula Anderson Vol#: 160

C 5279 Liana Paredes Vol#: 160

C 5280 Miriam Shakow Vol#: 160

C 5281 Pearl Watkins Vol#: 160

C 5282 Michael Govek Vol#: 160

C 5283 Fatma Obaid Vol#: 160

EMC 320 Scott Barnes Vol#: 160

EMC 321 Lauren Osornio Vol#: 160

99P-1340 Declared Eternity eau de Parfum Misbranded

C 700 Mary Kay Ellis Vol#: 18

EMC 305 Dwight Shackelford Vol#: 18

EMC 306 Brandy Sexton Vol#: 18

EMC 307 Louanne Mitchem Vol#: 18

EMC 308 Shelley Kramer Vol#: 18

EMC 309 Mary Jane Campbell Vol#: 18

EMC 310 Judith A. Stringer Vol#: 18

99P-4613 Revoke the Regulation That Approved Posilac

EMC 2391 Joanna Titchell Vol#: 44

EMC 2392 Maureen Alley Vol#: 44

99P-5106 Identify Sources of Natural Flavorings

EMC 74 Monica Vol#: 1

EMC 75 John Vol#: 1

EMC 76 Holland & Knight LLP Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 2154 Ms. Karen Hunt Vol#: 163

C 2155 Bonnie Beachy Vol#: 163

C 2156 Rochelle Roos Vol#: 163

C 2157 Chris Griffiths Vol#: 163

C 2158 Mark Goldberg Vol#: 163

C 2159 Donna Wolff Vol#: 163

C 2160 Nicole V. Mulkey Vol#: 163

C 2161 Rebecca Scherer Vol#: 163

C 2162 Susan Reichling Vol#: 163

C 2163 Kay McManus Vol#: 164

C 2164 Karen Enrgere Vol#: 164

C 2165 Karen Martelino Vol#: 164

C 2166 Charles J. Antonelei Vol#: 164

C 2167 Robert B. Maehr Vol#: 164

C 2168 Helen Barrett Vol#: 164

C 2169 Jim & Gera Cooper Vol#: 164

C 2170 Abby Perl Vol#: 164

C 2171 Henryka Roman Vol#: 164

C 2172 Mitzi Haggard Vol#: 164

C 2173 E. Randel Vol#: 164

C 2174 M. Nealu Vol#: 164

C 2175 Paul Maimone Vol#: 164

C 2176 D. Cooper Vol#: 164

C 2177 Dr. Julie Ann Allender Vol#: 164

C 2178 Capt H.M. Shay Vol#: 164

C 2179 Jashna Levine Vol#: 164

C 2180 John Goudreault Vol#: 164

C 2181 Jeffrey Rosen Vol#: 164

C 2182 Jenny Clark Vol#: 164

C 2183 M. Camp Vol#: 164

C 2184 Dr. Julie Ann Allender Vol#: 164

C 2185 Mrs. Sue S. Clutter Vol#: 164

C 2186 C. Jones Vol#: 164

C 2187 Bonnie Acker Vol#: 164

C 2188 Denver & Eileen Barnes Vol#: 164

C 2189 Rose Jordan-Nelson Vol#: 164

C 2190 Henry Thomas Vol#: 164

C 2191 Patricia Baratta Vol#: 164

C 2192 Ms. Connie F. Springer Vol#: 164

C 2193 Kathleen Nolan Vol#: 164

C 2194 Honey Province Vol#: 164

C 2195 Lillie Anderson Vol#: 164

C 2196 Marlene Cranmer Vol#: 164

C 2197 Vincent G. Franze Vol#: 164

C 2198 Eugene Pompilio Vol#: 164

C 2199 Catherine Mitchell Vol#: 164

C 2200 Cie Margo Vol#: 164

C 2201 Jane Vose Vol#: 164

C 2202 Edwardine Panepinto Vol#: 164

C 2203 Ms. Betty Good Vol#: 164

C 2204 Mrs. Winifred Johann Vol#: 164

C 2205 Levena Howard Vol#: 164

C 2206 Levena Howard Vol#: 164

C 2207 Levena Howard Vol#: 164

C 2208 Mary Alderson-Quinn Vol#: 164

C 2209 Edna Ball Vol#: 164

C 2210 Lila Sherman Vol#: 164

C 2211 Lynne Mulhall Vol#: 164

C 2212 Debrah Roemisah Vol#: 164

C 2213 Gary Davenport Vol#: 164

C 2214 Joan Davenport Vol#: 164

C 2215 Claire Seminario Vol#: 164

C 2216 Roberta Baggett Vol#: 164

C 2217 Cynthia Kolbe Vol#: 164

C 2218 Dianne Billings Vol#: 164

C 2219 K.M. Firchow Vol#: 164

C 2220 Calleen Livingston Vol#: 164

C 2221 Allison McCullough Vol#: 164

C 2222 Al Nourian Vol#: 164

C 2223 Carissa Green Vol#: 164

EMC 3201 Tami Augustyn Vol#: 162

EMC 3202 Wenty Vol#: 162

EMC 3203 Shelly Harper Vol#: 162

EMC 3204 Radames Soto Vol#: 162

EMC 3205 Cathy Cole Vol#: 162

EMC 3206 Thelma Garvin Vol#: 162

EMC 3207 Thelma Garvin Vol#: 162

EMC 3208 Leonard Barker Vol#: 162

EMC 3209 Margaret Almekinder Vol#: 162

EMC 3210 Margaret Almekinder Vol#: 162

EMC 3211 Drusilla Claridge Vol#: 162

EMC 3212 Kathy Carlise Vol#: 162

EMC 3213 Drusilla Claridge Vol#: 162

EMC 3214 Michael Lafkas Vol#: 162

EMC 3215 Michael Lafkas Vol#: 162

EMC 3216 Erin O'Brien Vol#: 162

EMC 3217 Dan Mulkerin Vol#: 162

EMC 3218 Kelly Fernandez Vol#: 162

EMC 3219 Nanette Campbell Vol#: 162

EMC 3220 Elizabeth Donsky Vol#: 162

EMC 3221 Susan Robinson, MD Vol#: 162

EMC 3222 Diane Lake Vol#: 162

EMC 3223 Cory Schaefer Vol#: 162

EMC 3224 Maryjean Robinson Vol#: 162

EMC 3225 Maryjean Robinson Vol#: 162

EMC 3226 Georgina Matthews Vol#: 162

EMC 3227 Dana Little Vol#: 162

EMC 3228 Robert Danos Vol#: 162

EMC 3229 Michael Giddings, PhD Vol#: 162

EMC 3230 Shasta Pistey-Lyhne Vol#: 162

EMC 3231 Shasta Pistey-Lyhne Vol#: 162

EMC 3232 Shasta Pistey-Lyhne Vol#: 162

EMC 3233 Laurie Tuttle, RN BSN Vol#: 162

EMC 3234 Ruth Stambaugh Vol#: 162

EMC 3235 Ruth Stambaugh Vol#: 162

EMC 3236 Christian D. Fine Vol#: 162

EMC 3237 Jon Dember Vol#: 162

EMC 3238 Drew Renner Vol#: 162

EMC 3239 Drew Renner Vol#: 162

EMC 3240 Kat Alessi Vol#: 162

EMC 3241 Sheri Hanson Vol#: 162

EMC 3242 Sheri Hanson Vol#: 162

EMC 3243 Sophia Morren Vol#: 162

EMC 3244 Martha Roberts Vol#: 162

EMC 3245 C M Vol#: 162

EMC 3246 Mark Kulda Vol#: 162

EMC 3247 Ann Ogle Vol#: 162

EMC 3248 Jennifer Walker Vol#: 162

EMC 3249 Malcolm Kenton Vol#: 162

EMC 3250 Alfred Willingham Jr. Vol#: 162

EMC 3251 Sandra L. Stone Vol#: 162

EMC 3252 Thomas Kozlovsky Vol#: 162

EMC 3253 Derek Wright Vol#: 162

EMC 3254 Maia Williams Vol#: 162

EMC 3255 Christina Robinson Vol#: 162

EMC 3256 Brenda Demos Vol#: 162

EMC 3257 Lauri Clegg Vol#: 162

EMC 3258 Kristin Doubet Vol#: 162

EMC 3259 Sister Claire Whalen, OSF Vol#: 162

00D-1662 Use of Xenotransplantation Products in Humans

C 3 Jessica Edwards Vol#: 3

C 4 Lorri L Francis Vol#: 3

C 5 Amer Association of Blood Banks Vol#: 3

C 6 America's Blood Centers Vol#: 3

C 7 Diacrin/Genzme Inc Vol#: 3

C 8 ABRA Vol#: 3

C 9 Nextran Incc Vol#: 3

EMC 77 Karina DeBow Vol#: 3

EMC 78 Louis J Sanso Jr Vol#: 3

EMC 79 Sylvia Laver Vol#: 3

EMC 80 Monica Jankowski Vol#: 3

EMC 81 Barbara Kurtz Vol#: 3

EMC 82 Erin Berry Vol#: 3

EMC 83 Heleen Walravin Vol#: 3

EMC 84 Barbara Gale Vol#: 3

EMC 85 Carol Marcus Vol#: 3

EMC 86 Dusty A Spitler Vol#: 3

EMC 87 Tracy Jordan Vol#: 3

EMC 88 Debby Campbell Vol#: 3

EMC 89 Katrina Miller Vol#: 3

EMC 90 Margaret Simpson Vol#: 3

EMC 91 Juan Diaz Vol#: 3

EMC 92 Prof C R Magel Vol#: 3

EMC 93 Lorraine Nicotera Vol#: 3

EMC 94 Pinky Jain Pan Vol#: 3

EMC 95 Dian Hardy Vol#: 3

EMC 96 Chloe Chadwick Vol#: 3

EMC 97 Jane DiFava Vol#: 3

00D-1681 Potassium Iodide as a Thyroid Blocking Agent

C 10 EPA Vol#: 1

C 11 UNIV Of CO Sciences Center Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 1663 Bonnie Beachy Vol#: 144

C 1664 Susan Connell Vol#: 144

EMC 2965 Susan Wunsch Vol#: 143

EMC 2966 Daniel Lipson Vol#: 143

EMC 2967 Jenny Schlieps Vol#: 143

EMC 2968 Robert M. Duffield Vol#: 143

EMC 2969 Paula L.N. Portinga Vol#: 143

EMC 2970 Patrick Handberg Vol#: 143

EMC 2971 Emily Cecil Vol#: 143

EMC 2972 Emily Cecil Vol#: 143

EMC 2973 Helen Shadowens Vol#: 143

EMC 2974 Robert Merrick Vol#: 143

EMC 2975 Jennifer Oliver Vol#: 143

EMC 2976 Todd Menlove Vol#: 143

EMC 2977 Dorothy Brown Vol#: 143

EMC 2978 Cathrine Grace Vol#: 143

EMC 2979 Christine Wind Vol#: 143

EMC 2980 Brenda Morris Vol#: 143

EMC 2981 Gretchen Muller Vol#: 143

EMC 2982 Phelps Jennifer Vol#: 143

EMC 2983 Geraldine Magante Vol#: 143

EMC 2984 John Crockett Vol#: 143

EMC 2985 Carrie F. Knox Vol#: 143

EMC 2986 Megan Hagler Vol#: 143

EMC 2987 Curtiss Pernice Vol#: 143

EMC 2988 Karen Ritterbusch Vol#: 143

EMC 2989 Raymond Eastman Vol#: 143

EMC 2990 T. Hoch Vol#: 143

EMC 2991 Kathleen Lare Vol#: 143

EMC 2992 Bruce N. Reynolds,MD Vol#: 143

EMC 2993 Lori Davis Vol#: 143

EMC 2994 Karen Moser Vol#: 143

EMC 2995 Lorrie Forster Vol#: 143

EMC 2996 Sharon Bodenschatz Vol#: 143

EMC 2997 Dr. Carley Henius Vol#: 143

EMC 2998 Liz Melbourne Vol#: 143

EMC 2999 Robert & Cynthia Sonnenberg Vol#: 143

EMC 3000 Susana Choy Vol#: 143

EMC 3001 Kimberly Click Vol#: 143

EMC 3002 Kimberly Click Vol#: 143

EMC 3003 Janet Chafe Vol#: 143

EMC 3004 Nancy Woods Vol#: 143

EMC 3005 Elaine Avery Vol#: 143

EMC 3006 Wayne Bailey Vol#: 143

EMC 3007 Anne Groom Vol#: 143

EMC 3008 Andrea Vardi Smith Vol#: 143

EMC 3009 Renee Honey Vol#: 143

EMC 3010 Liona Shareing Vol#: 143

EMC 3011 Leslie Smith Vol#: 143

EMC 3012 Michelle & Stuart Harris Vol#: 143

EMC 3013 G.R. Bond Vol#: 143

EMC 3014 Irene Wright Vol#: 143

EMC 3015 Amenra Tahotep Vol#: 143

EMC 3016 Jean Binder Vol#: 143

EMC 3017 Angela Maiorca Vol#: 143

EMC 3018 John & Darlene Grove Vol#: 146

EMC 3019 Craig Burch Vol#: 146

EMC 3020 Janet Ingraham Dwyer Vol#: 146

EMC 3021 Larry Kern & E.L. Kern Vol#: 146

EMC 3022 Eric Johnson Vol#: 146

EMC 3023 Patricia Briones Vol#: 146

EMC 3024 Misty Richmond Vol#: 146

EMC 3025 Hilda McNeer Vol#: 146

EMC 3026 Robert Flood Vol#: 146

EMC 3027 Roberto Ronchetti Vol#: 146

EMC 3028 Melissa Martin Vol#: 146

EMC 3029 Samantha Kaiser Vol#: 146

EMC 3030 Jeremy Bakelar Vol#: 146

EMC 3031 Heather Grant Vol#: 146

EMC 3032 Brian Anderson Vol#: 146

EMC 3033 Susan Holper Vol#: 146

EMC 3034 Kurt Konietzko Vol#: 146

EMC 3035 Flavio Casoy Vol#: 146

EMC 3036 Carolyn Heines Vol#: 146

EMC 3037 Kara Sprague Vol#: 146

EMC 3038 Paula Kamps Vol#: 146

EMC 3039 Deb Chichester Vol#: 146

EMC 3040 Lee Poynor,Ph.D. Vol#: 146

EMC 3041 Linda Price Vol#: 146

EMC 3042 Cara Meglio Vol#: 146

EMC 3043 Sarah Cress Vol#: 146

EMC 3044 John Walsh Vol#: 146

EMC 3045 Alexandra Parks Vol#: 146

EMC 3046 Cynthia Kerfoot Vol#: 146

EMC 3047 Karen Zeitz Vol#: 146

EMC 3048 Zeke Thomas Vol#: 146

EMC 3049 Michael Rottina Vol#: 146

EMC 3050 Jay Davis Vol#: 146

EMC 3051 The Kluter Family Vol#: 146

00N-1599 Use of Impact-Resistant Lenses in Eyeglasses and Sunglasses

NAL 1 Vol#: 1

S 1 SUPPORTING STATMENT Vol#: 1

00N-1637 Promotional Labeling for Drugs and Biologics for Human Use

N 2 Vol#: 1

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

C 10761 Ms Concetta L Fisichella Vol#: 750

C 10762 Rudy Cooper Jr Vol#: 750

C 10763 Eleanor G Brigden Vol#: 750

C 10764 Margaret P Morrison Vol#: 750

C 10765 Paul Kuhn Vol#: 750

C 10766 Carol R Shless Vol#: 750

C 10767 Stephanie Gialobbi Vol#: 750

C 10768 David Opp Vol#: 750

C 10769 Diane Kane Vol#: 750

C 10770 Matt Whitman Vol#: 750

C 10771 Mildred B Buggert Vol#: 750

C 10772 Lori Roland Vol#: 750

C 10773 Susan Hagstrom Vol#: 750

C 10774 Beth Ashton Vol#: 750

C 10775 Renee C Cauther Vol#: 750

C 10776 Peter & Margaret Child Vol#: 750

C 10777 Scott McGinley Vol#: 750

C 10778 Peggy Green Vol#: 750

C 10779 Susan Auglis Vol#: 750

C 10780 Chris Reed Vol#: 750

C 10781 Jean Peters Vol#: 750

C 10782 Jhym Phoenix Vol#: 750

C 10783 Gloria Winnick EdD Vol#: 750

C 10784 Judith Ferraris Vol#: 750

C 10785 Carol S Campbell Vol#: 750

C 10786 Habib Rathle, MD Vol#: 750

C 10787 Beverly Riverwood Vol#: 750

C 10788 Francesca Rago Vol#: 750

C 10789 Margaret S Reed Vol#: 750

C 10790 Sherry Cooper Vol#: 750

C 10791 Rachel Borgman Vol#: 750

C 10792 Elena Hammond Vol#: 750

C 10793 Suzi Johnson Vol#: 750

C 10794 Stephanie Palmer Vol#: 750

C 10795 Eve Ray Vol#: 750

C 10796 Robert Dands Vol#: 750

C 10797 Lizzy & Herb Pool Vol#: 750

C 10798 C T Bahr Vol#: 750

C 10799 Joshua Neubauer Vol#: 750

C 10800 Janis Ihrig Vol#: 750

C 10801 Jo Sprenger Vol#: 750

C 10802 Austin Sheldon Vol#: 750

C 10803 M Tauber Vol#: 750

C 10804 Masood Mokhtary Vol#: 750

C 10805 Stephen Grealy Vol#: 750

C 10806 Stephen J Allen Vol#: 750

C 10807 Ms Katharina Mava Vol#: 750

C 10808 Marie-Dolores Solano Vol#: 750

C 10809 Stacy A Wolf Vol#: 750

C 10810 Alisa Meggitt Vol#: 750

C 10811 Mrs Judy W Soffler Vol#: 750

C 10812 William R Russell Vol#: 750

C 10813 Darwin Wolf Vol#: 750

C 10814 Laura F Richardson Vol#: 750

EMC 4998 Debbie Garner Vol#: 750

EMC 4999 Renee Little Vol#: 750

00P-1322 Food Labeling and Allergen Contamination Control

C 95 Nancy Dwan Vol#: 4

C 96 Fay C Graning Vol#: 4

C 97 Barbara Tominson Vol#: 4

C 98 Deborah Smith Vol#: 4

C 99 J Barton Vol#: 4

C 100 Barbara Ann Smith Vol#: 4

C 101 Pauline Wickham Vol#: 4

C 102 Helen D Haller Vol#: 4

C 103 Nelson Han Vol#: 4

C 104 John J Ahearn Vol#: 4

C 105 Marvin Rothfusz Vol#: 4

C 106 Jack Mandel Vol#: 4

C 107 Don Lipton Vol#: 4

EMC 20 CSPI Vol#: 4

EMC 21 Anne K Auburn Vol#: 4

01D-0025 Guidance for Industry - Yellow Corn & Dry-Milled

C 2 North American Millers' Association Vol#: 1

01D-0044 Clinical Laboratory Improvement Amendments of 1988

C 5 Serim Research Corp. Vol#: 1

01D-0185 Providing Regulatory Submissions in Electronic Format

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

01D-0194 Statistical Aspects Design,Analysis,Interpretation,chronic

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

01E-0225 Patent Term Extension Application, CANCIDAS No. 5,514,650

APP 1 Merck & Co., Inc. Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

M 1 HFD-7 Vol#: 1

01E-0229 Patent Term Extension Application, PAYLEAN No. 4,690,951

APP 1 Eli Lilly & Company Vol#: 1

LET 1 U.S. Patent & Trademark Office Vol#: 1

M 1 HFD-7 Vol#: 1

01N-0006 New Animal Drug Application, Form FDA 356 V, 21 CFR PART 514

N 2 Vol#: 1

01P-0228 Clarify the"intended use of" regulated/labeling products

ACK 1 HFA-305 Vol#: 1

CP 1 Bennett,Turner & Coleman,LLP Vol#: 1