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 March 29, 2001

TABLE OF CONTENTS

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98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
00P-1411 Set a regulatory limit for methylmercury in seafood *
01P-0156 ANDA Suitability for Ketamine Hydrochloride Injection *

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 807 Shari Wildschutte Vol#: 41

C 808 S Iris Clarke Vol#: 41

C 809 Patricia A Pearson Vol#: 41

EMC 165 Audrey Lyle Vol#: 41

EMC 166 Mrs V A Schechter Vol#: 41

EMC 167 Chad D Durr Vol#: 41

EMC 168 Erich Brough Vol#: 41

EMC 169 Cory Schaefer Vol#: 41

EMC 170 Carrie F Knox Vol#: 41

EMC 171 Janet Chafe Vol#: 41

EMC 172 Kerri Mikkelsen Vol#: 41

EMC 173 Thalia Schlossberg Vol#: 41

EMC 174 Jan Stern Vol#: 41

EMC 175 Julie Ashmore Vol#: 41

EMC 176 James & Katherine Ashmore Vol#: 41

EMC 177 Vera Wilson Vol#: 41

EMC 178 Judy & Danie Dishman Vol#: 41

EMC 179 Beverly White Vol#: 41

EMC 180 Georgette Peterson Vol#: 41

EMC 181 Melissa McDaniel Vol#: 41

EMC 182 Tricia Riley Vol#: 41

EMC 183 Marisha Auerbach Vol#: 41

EMC 184 Martin Matlin Vol#: 41

EMC 185 Renee Miralda Vol#: 41

EMC 186 A C Vol#: 41

EMC 187 Sharon Bauer Vol#: 41

EMC 188 unsigned Vol#: 41

EMC 189 Wendy Crumpler Vol#: 41

EMC 190 Stuart Gillespie Vol#: 41

EMC 191 Cynthia Hagen Vol#: 41

99D-4396 Financial Disclosure By Clinical Investigators

GDL 2 Guideline Vol#: 1

NAD 2 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2928 Wanda Trinkle Vol#: 205

C 2929 Ryan M Troyer Vol#: 205

C 2930 Richard M Peters MD Vol#: 205

C 2931 Heather Olivier Vol#: 205

C 2932 Michael Windelspecht PhD Vol#: 205

C 2933 Dr D G Tanenbaum Vol#: 205

C 2934 Tom & Sharon Baring Vol#: 205

C 2935 Jean P Patterson Vol#: 205

C 2936 Anna Harlowe Vol#: 205

C 2937 Anna Sabateanski Vol#: 205

C 2938 Elaine F Livesey Vol#: 205

C 2939 Jacob W E Dijkstra MD Vol#: 205

C 2940 Edwine Schulmon-Andrews Vol#: 205

C 2941 Greg Edblom Vol#: 205

C 2942 Kathy H Moles Vol#: 205

C 2943 Philip & Zlata Hartman Vol#: 205

C 2944 Brenda Aguilar Vol#: 205

C 2945 Brian L Strom MD Vol#: 205

C 2946 Rachael Lyon Vol#: 205

C 2947 Kathy Anderson Vol#: 205

C 2948 Debra Kirchhof-Glazier PhD Vol#: 205

C 2949 William & Rose Webster Vol#: 205

C 2950 Eleanor L Jones Vol#: 205

C 2951 Jan Kren Vol#: 205

C 2952 Bernadette M Sonfeld Vol#: 205

C 2953 June Chambers Vol#: 205

C 2954 Jeanne Young Vol#: 205

C 2955 Andrea Bisop & M R Churichick Vol#: 205

C 2956 Glenda L Haase Vol#: 205

C 2957 Karma Vol#: 205

C 2958 Sandy L Wagner Vol#: 205

C 2959 Illegible Vol#: 205

C 2960 Yonetta Asin Vol#: 205

C 2961 Joan L Harrod Vol#: 205

C 2962 Marilyn Webb Vol#: 205

C 2963 Kristy Boettler Vol#: 205

C 2964 Martha Gomez Vol#: 205

C 2965 Shirley Aumock Vol#: 205

C 2966 Claire Martineau Vol#: 205

C 2967 S Hone Vol#: 205

C 2968 Elizabeth M Bonnett Vol#: 205

C 2969 Janice Kroll Vol#: 205

C 2970 Erin Williams Vol#: 205

C 2971 Andrea Moeckel Vol#: 205

C 2972 Teresa Kennedy Vol#: 205

C 2973 Penny McNeal Vol#: 205

C 2974 Melinda Beegle Vol#: 205

C 2975 Jane E Sawwell Vol#: 205

C 2976 Alice E Schofield Vol#: 205

C 2977 Horace & Hope Coburn Vol#: 205

C 2978 Jane W Robertson Vol#: 205

C 2979 Robin Wright Vol#: 205

C 2980 Evelyn K Parent & 22 members of family Vol#: 205

C 2981 Gayle N Tizzio Vol#: 205

C 2982 Sistine C Callen Vol#: 205


00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 323 Form Letter Count Vol#: 41

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

C 9 Gerald Carlin Vol#: 1

C 10 Thomas F Hall Vol#: 1

C 11 Lauretta Clowes Vol#: 1

C 12 MaryAnn Ostruski Vol#: 1

C 13 Frances F Fuller Vol#: 1

EMC 2 Dairy300 Vol#: 1

EMC 3 Dale Schmidt Vol#: 1

EMC 4 Gail Carstensen Vol#: 1

EMC 5 Fred & Dani LaClair Vol#: 1


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

C 9174 Emma Jane Saxe Vol#: 722

C 9175 Ginni Callow Vol#: 722

C 9176 Kerry Culver Vol#: 722

C 9177 Donna Koss Vol#: 722

C 9178 Dana Visse Vol#: 722

C 9179 Milan Seethoff Vol#: 722

C 9180 Carlton Schreiner Vol#: 722

C 9181 Derk Sims Vol#: 722

C 9182 Hollis Orr Vol#: 722

C 9183 David Logar Vol#: 722

C 9184 Robin Boyer Vol#: 722

C 9185 Joy L Cristino Vol#: 722

C 9186 C Morris Vol#: 722

C 9187 Laura Clark Vol#: 722

C 9188 Cecile L Claude Vol#: 722

C 9189 Maria Flecle Vol#: 722

C 9190 Margaret J Gentile Vol#: 722

C 9191 Carl Morse Vol#: 722

C 9192 Maiden Carpenter Vol#: 722

C 9193 Jack W Goodwin Vol#: 722

C 9194 Mark Theher Vol#: 722

C 9195 Ruth B Rodwick Vol#: 722

C 9196 S N Martin Vol#: 722

C 9197 Emilo Bisson Vol#: 722

C 9198 Charles B England Vol#: 722

C 9199 Rachel Crystalbird Vol#: 722

C 9200 Edward Teyssier Vol#: 722

C 9201 Mark Gregory Vol#: 722

C 9202 Alison Holland Vol#: 722

C 9203 Masako Ishikawa Vol#: 722

C 9204 C Vazquez Vol#: 722

C 9205 Diane Tissot Vol#: 722

C 9206 Carol Crawford Vol#: 722

C 9207 H Leon Bradlow Vol#: 722

C 9208 Louis A Novellino Vol#: 722

C 9209 John Thomas Vol#: 722

C 9210 Christine Ostopoff Vol#: 722

C 9211 Amalie C S Callahan Vol#: 722

C 9212 Randy Selig Vol#: 722

C 9213 Pauline Van Meter Vol#: 722

C 9214 C A O'Donnell Vol#: 722

C 9215 Jonathan Strong Vol#: 722

C 9216 Howard E Miller Vol#: 722

C 9217 C Doucel and family Vol#: 722

C 9218 Ben and Paola Bowmaster & family Vol#: 722

C 9219 Bill Hehler Vol#: 722

00P-1411 Set a regulatory limit for methylmercury in seafood

EMC 69 Mary Krane Derr Vol#: 1

EMC 70 Mary Krane Derr Vol#: 1

EMC 71 Christopher Schutz Vol#: 1

01N-0126 Bottled water quality standard: allowable levels/disinfectan

BKG 1 Background Material Vol#: 2

NFR 1 Vol#: 1

NPR 1 Vol#: 1

01P-0156 ANDA Suitability for Ketamine Hydrochloride Injection

ACK 1 HFA-305 Vol#: 1

CP 1 Bioniche Pharma (Canada) Ltd. Vol#: 1

01V-0155 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Tropics Vol#: 1