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 February 13, 2001

TABLE OF CONTENTS

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78N-0038 Sunscreen Drug Products *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
97N-0436 Methods informing consumers of contents of bottle water *
98N-1038 Irradiation in the production, processing, &handling of food *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-4613 Revoke the Regulation That Approved Posilac *
00D-1563 Industry on Carcinogenicity Study protocol submissions *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1601 Guidance for Industry and for FDA Employees on Import Alert *
00N-0989 Human Gene Therapy *
00N-1269 Labeling for human prescription drug/Biologic Products *
00N-1380 Human Bone Allograft;Orthopedic Reconstruction & Repair *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00N-1682 Radioactive Drug Research Committee *
00P-1411 Set a regulatory limit for methylmercury in seafood *

78N-0038 Sunscreen Drug Products

C 591 Procter & Gamble Vol#: 146

C 592 Advanced Dermatology & Cosmetic Care Vol#: 146

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

C 2202 Susan Pivnick Vol#: 64


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

C 225 Linde Westling Vol#: 7

C 226 Joan Craco Vol#: 7

C 227 Bob & Connie Maresca Vol#: 7

98N-0044 Effect of dietary supplement on structure/function of body

C 22414 CSPI, Ctr. for Science in the Public Int Vol#: 883

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

C 5223 Form Letters count 23 Vol#: 154

EMC 239 Public Citizen/HRG/LG Vol#: 151

EMC 240 Kristen B. Decker Vol#: 151

EMC 241 Sonya Lopes Vol#: 151

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

C 3812 Marvin Pershin Vol#: 119

C 3813 Donna E. Young Vol#: 119

C 3814 Dr. & Mrs. Jerry Hoffman Vol#: 119

C 3815 The Peaceful Kingdom Alliance 4 Animals, Vol#: 119

C 3816 M. Waldron Vol#: 119

C 3817 Jennifer van Wyck Vol#: 119

C 3818 Ms. K. Kovach Vol#: 119

C 3819 Mr. Arun Kantharia Vol#: 119

C 3820 WAGDOG Vol#: 119

C 3821 Christel L. Voelske Vol#: 119

C 3822 API, Animal Protection Institute Vol#: 119

C 3823 Rudy's Markets Vol#: 120

EMC 1087 Mertens Rosa (Belgie) Vol#: 119

EMC 1088 Diana Dowell Vol#: 119

EMC 1089 Mary Jane Del Vicario Vol#: 119

EMC 1090 Ms. Dawn Masturzo Vol#: 119

EMC 1091 Courtney Cione Vol#: 119

EMC 1092 R. Reichert Vol#: 119

EMC 1093 Betty Jean Herner Vol#: 119

EMC 1094 Mary L. Uhlemeyer Vol#: 119

EMC 1095 Deborah N. Black, M.D. Vol#: 119

EMC 1096 Scott Kadick Vol#: 119

EMC 1097 BEHUMANE2 Vol#: 119

EMC 1098 Melissa Chisena Vol#: 119

EMC 1099 Alecs Sakta Vol#: 119

EMC 1100 Sue Ann Patterson Vol#: 119

EMC 1101 Christine Morrissey Vol#: 119

EMC 1102 Yvonne Kravitz Vol#: 119

EMC 1103 Fernando Mendes Vol#: 119

99P-1340 Declared Eternity eau de Parfum Misbranded

C 675 Beverly J. Ezra Vol#: 16

C 676 Linda Anderson Vol#: 16

EMC 215 Joyce Zook Vol#: 16

EMC 216 Steven C. Rowat Vol#: 16

EMC 217 Yorick Phoenix Vol#: 16

EMC 218 John Cailleau Vol#: 16

EMC 219 Rhonda Murphy Vol#: 16

EMC 220 Marsh D. McCord Vol#: 16

EMC 221 Sherrie Vol#: 16

99P-4613 Revoke the Regulation That Approved Posilac

C 1372 Bee McCormack Vol#: 44

C 1373 Jim Cervelli Vol#: 44

C 1374 Nancy Wygant Vol#: 44

C 1375 Erin Russell Vol#: 44

C 1376 Nancy Pepin Vol#: 44

C 1377 Tiana Marie Petit Vol#: 44

C 1378 Jerri Brandt Vol#: 44

C 1379 Robert & Stephanie Rivera Vol#: 44

C 1380 Mrs. Pamela M. Wierengo Vol#: 44

C 1381 Fatma Obaid Vol#: 44

C 1382 Gina Clifford Vol#: 44

EMC 2371 Chelsie Callan Vol#: 44

EMC 2372 Donna Macaluso Vol#: 44

EMC 2373 Joseph Macaluso Vol#: 44

00D-1563 Industry on Carcinogenicity Study protocol submissions

C 1 Bristol-Myers Squibb Vol#: 1


00D-1598 Voluntary Labeling for Bioengineered Foods

C 174 Form Letter Vol#: 21

C 175 Edmond K. Wilson Vol#: 22

C 176 Leslie Pierpont Vol#: 22

C 177 Henry Peck Vol#: 22

C 178 Lar Varley Vol#: 22

C 179 Andrew T. Fisher Vol#: 22

C 180 Helen Garrison Vol#: 22

C 181 Evangeline Cinkus Vol#: 22

C 182 Thelma Correll Vol#: 22

C 183 FBR Vol#: 22

C 184 Andy M. Scott Vol#: 22

C 185 Sandra Bryan Vol#: 22

C 186 Marthew D. Hensley Vol#: 22

C 187 Melissa Vol#: 22

C 188 Andrew Ridley Vol#: 22

C 189 Lyn Brick Vol#: 22

C 190 Lisa Tarres Vol#: 22

C 191 Jeannette Oliver Vol#: 22

C 192 Danie Derick Vol#: 22

C 193 Nancy Stern Vol#: 22

C 194 Chris Niles Vol#: 22

C 195 Randi Lambera Vol#: 22

C 196 Natalie Hotchkiss Vol#: 22

C 197 Barbara Vol#: 22

C 198 Claire Gallagher Vol#: 22

C 199 Sarah Bateman Vol#: 22

C 200 Kit Cooper Vol#: 22

C 201 Sandy Freeman Vol#: 22

C 202 Christopher Knerr Vol#: 22

C 203 Madeline S. Vol#: 22

C 204 Marqaret Viers Vol#: 22

C 205 Carmela M. Federico Vol#: 22

C 206 Ted LaPage Vol#: 22

C 207 Loreli Fister Vol#: 22

C 208 Eliza F. Hitchcock Vol#: 22

C 209 Josie Pradella Vol#: 22

C 210 Jennifer Schieffer Vol#: 22

C 211 Gary Boyer Vol#: 22

C 212 Jerry McGeorge Vol#: 22

C 213 Gary A. Patton Vol#: 22

C 214 Paul Tarabek Vol#: 22

C 215 Charles W. Monaghan Vol#: 22

C 216 Charles Monaghan Vol#: 22

C 217 Charles Monaghan Vol#: 22

C 218 Jill Baratta Vol#: 22

C 219 Marion Goodale Vol#: 22

C 220 Maria Vol#: 22

C 221 Leary P Vol#: 22

C 222 Larry P Vol#: 22

C 223 Bradley Clement Vol#: 22

C 224 Jessica Sapmor Vol#: 22

C 225 Jack Bronacini Vol#: 22

C 226 Francis Olsen Vol#: 22

C 227 Matthew Saavedra Vol#: 22

C 228 Kate Garrison Vol#: 22

C 229 Jammie Brown Vol#: 22

C 230 Joice Scarelli Vol#: 22

C 231 F. Erickson Vol#: 22

C 232 Tami Augustyn Vol#: 22

C 233 Michiko Clark Vol#: 22

C 234 Natalie Hildt Vol#: 22

C 235 Marelyn M. Ashley Vol#: 22

C 236 Hally M. Baker Vol#: 22

C 237 Stacey Khlifa Vol#: 22

C 238 Thomas S. Woodruff Vol#: 22

C 239 Gwen Mehring Vol#: 22

C 240 Susan Hudson Vol#: 22

C 241 Ruth & Ted Swain Vol#: 22

C 242 Jean Wheeler Vol#: 22

C 243 Helvi McClelland Vol#: 22

C 244 Elizabeth Douglas Vol#: 22

C 245 Deborah Marshall Vol#: 22

C 246 Tayna Avery Vol#: 22

C 247 Catherine H. Vol#: 22

C 248 Alice Dugar Snd Vol#: 22

C 249 Kenneth Johnson Vol#: 22

C 250 Maribeth Seely Vol#: 22

EMC 526 Charles Wyrostok Vol#: 24

EMC 527 Gary Lawton Vol#: 24

EMC 528 Catherine Munson Vol#: 24

EMC 529 David Anthes Vol#: 24

EMC 530 Regan Nally Vol#: 24

EMC 531 Penny Lynn Dunn Vol#: 24

EMC 532 Richard Gardner Vol#: 24

EMC 533 Lulu Vol#: 24

EMC 534 Laura Halpin Vol#: 24

EMC 535 Carol Fabos-Gruba Vol#: 24

EMC 536 Number Not Used Vol#: 24

EMC 537 Number Not Used Vol#: 24

EMC 538 Kathleen Hill Vol#: 24

EMC 539 Jennifer Mollett Vol#: 24

EMC 540 Number Not Used Vol#: 24

EMC 541 W.F. Wolfe Jr. Vol#: 24

EMC 542 Thomas Taylor Vol#: 24

EMC 543 Coeta Mills Vol#: 24

EMC 544 Debra Peterson Vol#: 24

EMC 545 Gary Smith Vol#: 24

EMC 546 Amy Conry Vol#: 24

EMC 547 Diane Dee Vol#: 24

EMC 548 Patricia Snouffer Vol#: 24

EMC 549 Jesse Herbert Vol#: 24

00D-1601 Guidance for Industry and for FDA Employees on Import Alert

C 4 Dupont Pharmaceuticals Co Vol#: 1

C 5 Generic Pharmaceutical Assn Vol#: 1

00N-0989 Human Gene Therapy

C 2 Mark Hochhauser PhD Vol#: 1

00N-1256 Over-the-Counter Drug Products;Public Hearing

EMC 4 Lisa Castilho Vol#: 24

00N-1269 Labeling for human prescription drug/Biologic Products

C 2 Harold V Silver Vol#: 2

C 3 Frederic J Marsik PhD Vol#: 2

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

C 24 Teva Pharmaceutical Vol#: 2

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

C 32 Orthopedic Surgical Mfr Assn Vol#: 2


00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 45 R Johnson Vol#: 9

C 46 S Mareau Vol#: 9

C 47 Unreadable Vol#: 9

C 48 Unreadable Vol#: 9

C 49 G K Shriver Vol#: 9

C 50 Unreadable Vol#: 9

C 51 V Mata Vol#: 9

C 52 D G Fazio Vol#: 9

C 53 Sara, Sky et al Vol#: 9

C 54 J L Wright Vol#: 9

C 55 R A Schiller Vol#: 9

C 56 Unreadable Vol#: 9

C 57 Unreadable Vol#: 9

C 58 Melissa B Vol#: 9

EMC 7 L Huta Vol#: 9

EMC 8 K Kurtz Vol#: 9

EMC 9 C Melby Vol#: 9

EMC 10 D Gallimore Vol#: 9

EMC 11 D Shelton Vol#: 9

EMC 12 I E Price Vol#: 9

EMC 13 P H Coe Vol#: 9

EMC 14 M Booz Vol#: 9

EMC 15 K Spencer Vol#: 9

EMC 16 S McTighe Vol#: 9

EMC 17 M Davis, M.D. Vol#: 9

EMC 18 L Allard Vol#: 9

EMC 19 K Z Vayda Vol#: 9

EMC 20 D B G Nicholl Vol#: 9

EMC 21 S Mullally Vol#: 9

EMC 22 M Dolan Vol#: 9

00N-1682 Radioactive Drug Research Committee

C 1 UN of Iowa Health Care Vol#: 1


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

EMC 2 John Barfield Vol#: 1

EMC 3 John Barfield Vol#: 1

EMC 4 Paul Wright Vol#: 1

EMC 5 Paul Wright Vol#: 1

EMC 6 Matthew Lasley Vol#: 1

EMC 7 Matthew Lasley Vol#: 1

EMC 8 Amy Grubert Vol#: 1

EMC 9 Amy Grubert Vol#: 1

EMC 10 Brent Johnson Vol#: 1

EMC 11 Brent Johnson Vol#: 1

EMC 12 Rachel Berger Vol#: 1

EMC 13 Rachel Berger Vol#: 1

EMC 14 Julie Miller Vol#: 1

EMC 15 Julie Miller Vol#: 1

EMC 16 Cascade DuSel Vol#: 1

EMC 17 Cascade DuSel Vol#: 1

EMC 18 Ruth (personal request) Vol#: 1

EMC 19 Ruth (personal request) Vol#: 1

EMC 20 James Spaulding Vol#: 1

EMC 21 James Spaulding Vol#: 1

EMC 22 William Shepard Vol#: 1

EMC 23 William Shepard Vol#: 1

EMC 24 Bonnie Barnes Vol#: 1

EMC 25 Bonnie Barnes Vol#: 1

EMC 26 Nicholas Gausling Vol#: 1

EMC 27 Nicholas Gausling Vol#: 1

EMC 28 Keir Mussen Vol#: 1

EMC 29 Keir Mussen Vol#: 1

EMC 30 Amy Hodman Vol#: 1

EMC 31 Amy Hodman Vol#: 1

EMC 32 Rev. Lauren Benjamin Vol#: 1

EMC 33 Rev. Lauren Benjamin Vol#: 1

EMC 34 Johnson Bettelynn Vol#: 1

EMC 35 Johnson Bettelynn Vol#: 1

EMC 36 Margaret Walsh Vol#: 1

EMC 37 Margaret Walsh Vol#: 1

EMC 38 Erin Pasternack Vol#: 1

EMC 39 Erin Pasternack Vol#: 1

EMC 40 Ronald Chiodi Vol#: 1

EMC 41 Ronald Chiodi Vol#: 1

EMC 42 Kathleen & Tom Washburn Vol#: 1

EMC 43 Kathleen & Tom Washburn Vol#: 1

EMC 44 Karen Sanchirico Vol#: 1

EMC 45 Karen Sanchirico Vol#: 1

EMC 46 Bonnie Conley Vol#: 1

EMC 47 Melissa Dorval Vol#: 1

EMC 48 Herb Ridge Vol#: 1

EMC 49 Louise Collins Vol#: 1

EMC 50 Delores Ward Vol#: 1

EMC 51 Delores Ward Vol#: 1

EMC 52 Leslie Marshall Vol#: 1

EMC 53 Leslie Marshall Vol#: 1

EMC 54 Kathryn Lorenz Vol#: 1

EMC 55 Kathryn Lorenz Vol#: 1

EMC 56 Pamela Hosler Vol#: 1

EMC 57 Pamela Hosler Vol#: 1

EMC 58 Pamela Sherman Vol#: 1

EMC 59 Pamela Sherman Vol#: 1

EMC 60 Ben Smith Vol#: 1

EMC 61 Ben Smith Vol#: 1

EMC 62 Robert Sapp Vol#: 1

EMC 63 Robert Sapp Vol#: 1

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

C 3 Virginia Halt Vol#: 1

C 4 Florence Klem Vol#: 1