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 November 16, 2001

TABLE OF CONTENTS

Hyper links are part of the Docket  title - not all dockets/documents are linked

NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet.

PLEASE DO NOT  include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
98N-1038 Irradiation in the production, processing, &handling of food *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99F-5322 Ionizing Radiation for the Treatment of Food *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-0989 Human Gene Therapy *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
01D-0220 Biological Prod Deviation Reporting for Blood & Plasma Estab *
01D-0221 Biological Product Deviation Reporting for Licensed Manufact *
01D-0278 Submitting Type V Drug Master Files to Center for Biologics *
01D-0368 Submitting Marketing Applications according to ICH/CTD Forma *
01P-0228 Clarify the"intended use of" regulated/labeling products *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
77N-0085 Saccharin and Its Salts

CA 16005 Number Not Used Vol#: 381

CA 16053 Number Not Used Vol#: 381

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

C 36 Ammerican Assn of Blood Banks Vol#: 4

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

EMC 440 Harry Stephens Vol#: 173

EMC 441 Harry Stephens Vol#: 173

EMC 442 Aaron Henne Vol#: 173

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

C 5324 Hammacher Schlemmer Vol#: 190

EMC 2548 Kelly MacGrady Vol#: 188

EMC 2549 Donna Cray Vol#: 188

EMC 2550 Brian & Phyllis Herrell Vol#: 188

EMC 2551 Meg Allison Vol#: 188

EMC 2552 Rhonda Fife Vol#: 188

EMC 2553 Leslie Varela Vol#: 188

EMC 2554 Kari Pond Vol#: 188

EMC 2555 Angelica Rodriuez Vol#: 188

EMC 2556 Lionel Friedberg Vol#: 188

EMC 2557 Heather Bialy Vol#: 188

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

EMC 295 David Calvani Vol#: 43

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 2 Center for Food Safety Vol#: 1

EMC 3 Herb Jacobs Vol#: 1

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 4 Center for Food Safety Vol#: 1

EMC 5 Herb Jacobs Vol#: 1

99N-0035 Medical Devices; Reclassification of 38 Preamendments

NFR 3 Vol#: 2

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

EMC 3492 Jesica Ball Vol#: 505

00D-1543 Electronic Signatures: Glossary of Terms

C 1 Bruce L. Hogle Vol#: 5

00D-1557 Indwelling Blood Gas Analyzer 510(k)

NAD 2 Vol#: 1

00D-1558 Electrical Safety, Electromagnetic Capatibility & Mech Test

NAD 2 Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9582 Marie B. Olwell Vol#: 476

C 9583 K. Menon Vol#: 476

C 9584 5 signatures Vol#: 476

C 9585 7 signatures Vol#: 476

C 9586 Jerome P. Kenyon Vol#: 476

C 9587 Eligible Vol#: 476

C 9588 Renny Nocera Vol#: 476

00N-0989 Human Gene Therapy

EMC 146 Silvia Martinotti Vol#: 8

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9144 An angel Vol#: 401

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

C 17 Lifeline Tachnologies, Inc. Vol#: 18

00P-1276 Health Claim: Plant stanol esters and heart disease

C 20 Lifeline Tachnologies, Inc. Vol#: 18

01D-0220 Biological Prod Deviation Reporting for Blood & Plasma Estab

EMC 1 America Blood Centers Vol#: 1

EMC 2 Alpha Therapeutic Corporation Vol#: 1

01D-0221 Biological Product Deviation Reporting for Licensed Manufact

C 6 Aventis Pasteur Vol#: 1

01D-0278 Submitting Type V Drug Master Files to Center for Biologics

C 1 Aventis Pharmaceuticals Vol#: 1

01D-0368 Submitting Marketing Applications according to ICH/CTD Forma

EMC 1 Janet V. Ehlert Vol#: 1

01N-0238 Exemptions from Premarket Notification; Class II Devices

NFR 1 Vol#: 1

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

LET 1 HF-1 to Bennett,Turner & Coleman,LLP Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 1144 Dorcas R. McCall Vol#: 49

EMC 1145 number not used Vol#: 49

EMC 1146 R. Seidler Vol#: 49

EMC 1147 Rebecca Kinn Vol#: 49

EMC 1148 Aileen Bellwood Vol#: 49

EMC 1149 Ruth Davis Vol#: 49

EMC 1150 Lynette Horner Vol#: 49

EMC 1151 Marie Pendzich Vol#: 49

EMC 1152 Portia Mottola Vol#: 49

EMC 1153 Mark M. Giese Vol#: 49

EMC 1154 Jonathan Furst Vol#: 49

EMC 1155 Russ Lux Vol#: 49

EMC 1156 Matthew Monsoor Vol#: 49

EMC 1157 Jeffrey Cozy Vol#: 49

EMC 1158 Sharon Vadas Vol#: 49

EMC 1159 Tom Sutherland Vol#: 49

EMC 1160 Igor Kiselev Vol#: 49

EMC 1161 Linda Neale Vol#: 49

EMC 1162 Lane Utley Vol#: 49

EMC 1163 number not used Vol#: 49

EMC 1164 Mark Preston Vol#: 49

EMC 1165 Susannah Frishman-Phillips Vol#: 49

EMC 1166 Burnis E. (Gene) Tuck Vol#: 49

EMC 1167 Susan Rogers Vol#: 49

EMC 1168 Natasha & Noah Brenner Vol#: 49

EMC 1169 Floyd and Natalie Cranmer Vol#: 49

EMC 1170 Pat Bily Vol#: 49

EMC 1171 James Bash Vol#: 49

EMC 1172 Eva Martin Vol#: 49

EMC 1173 Clifford Garner Vol#: 49

EMC 1174 Anna Miller-Tiedman Vol#: 49

EMC 1175 number not used Vol#: 49

EMC 1176 Sarah Reagan Vol#: 49

EMC 1177 Meryl Gorge Vol#: 49

EMC 1178 Karla Welsh Vol#: 49

EMC 1179 Jane DiFava Vol#: 49

EMC 1180 Jane W. Elioseff Vol#: 49

EMC 1181 M. Scott Jones Vol#: 49

EMC 1182 Patricia M. Rodgers Vol#: 49

EMC 1183 Susan McMillan Vol#: 49

EMC 1184 Dr. and Mrs. Gerson Lesser Vol#: 49

EMC 1185 Merion M. Sharp Vol#: 49

EMC 1186 Theresa Pizzuto Vol#: 49

EMC 1187 Michael Mirtsopoulos Vol#: 49

EMC 1188 Michael Cerkowski Vol#: 49

EMC 1189 Catherine Muller Vol#: 49

EMC 1190 Debra DiLallo Vol#: 49

EMC 1191 Lacy Syverson Vol#: 49

EMC 1192 Jerri Lafeber Vol#: 49

EMC 1193 Jeff Allin Vol#: 49

EMC 1194 Tomas Arredondo Vol#: 49

EMC 1195 Michael Stephens Vol#: 49

EMC 1196 Lucille Balukjian Vol#: 49

EMC 1197 Carol C. Wagner Vol#: 49

EMC 1198 Tammy Gersh Vol#: 49

EMC 1199 Martha Booz Vol#: 49

EMC 1200 Ruselle Rubine and David Rubine Vol#: 49

EMC 1201 Carole Keene Vol#: 49

EMC 1202 Matt Behrmann Vol#: 49

EMC 1203 number not used Vol#: 49

EMC 1204 Julie Duncan Vol#: 49

EMC 1205 Brian Henk Vol#: 49

EMC 1206 Sarah Bandomer Vol#: 49

EMC 1207 Katherine E. Sipiorski Vol#: 49

EMC 1208 Irene Kitzman, MD Vol#: 49

EMC 1209 William Shuford, Jr. Vol#: 49

EMC 1210 Cynthia Christensen Vol#: 49

EMC 1211 Edwin Nunez Vol#: 49

EMC 1212 Danny Pazos Vol#: 49

EMC 1213 Anna Collins Vol#: 49

EMC 1214 Hans Kretschmer Vol#: 49

EMC 1215 Samie Decker Vol#: 49

EMC 1216 Marie I. Cochran Vol#: 49

EMC 1217 Geoff Eisen Vol#: 49

EMC 1218 Aryn Colkett Vol#: 49

EMC 1219 Paula Kaartinen Vol#: 49

EMC 1220 Jean H. Jorgensen Vol#: 49

EMC 1221 Janet M. Walsh Vol#: 49

EMC 1222 Michael Danielson Vol#: 49

EMC 1223 Penny Lynn Dunn Vol#: 49

EMC 1224 Karen Cutler Vol#: 49

EMC 1225 Carmen A. Klucsor Vol#: 49

EMC 1226 Russell Beard Vol#: 49

EMC 1227 Jim Darrar Vol#: 49

EMC 1228 Bruce Daniel Vol#: 49

EMC 1229 Caitlin Daniel Vol#: 49

EMC 1230 Sheldon Nicholl Vol#: 49

EMC 1231 Jim Edwards Vol#: 49

EMC 1232 Deborah Shoval Vol#: 49

EMC 1233 Carol J. Meyer Vol#: 49

EMC 1234 Alicia Oldfield Vol#: 49

EMC 1235 James D. Whiddon Vol#: 49

EMC 1236 Ruth Black Vol#: 49

EMC 1237 Vera Traylor Vol#: 49

EMC 1238 Afton Surwillo Vol#: 49

EMC 1239 Paul Schmitt Vol#: 49

EMC 1240 Emily Carlson Vol#: 49

EMC 1241 Angela Wright Vol#: 49

EMC 1242 Diane H. Norcross Vol#: 49

EMC 1243 Suzanne St. Germain Vol#: 49

EMC 1244 Master Berk K.S.C./Ethan Brown Vol#: 49

EMC 1245 Mariana Wood Vol#: 49

EMC 1246 Jonathan Blitstein Vol#: 49

EMC 1247 Karl J. Volk Vol#: 49

EMC 1248 Erin Reilly Vol#: 49

EMC 1249 Collette Davis Vol#: 49

EMC 1250 Kenneth Hasenfus Vol#: 49