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 27, 2001

TABLE OF CONTENTS

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90N-0361 Food Labeling, Declaration of Ingredients *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1618 Blood collection/persons with Hereditary Hemochromatosis *
00D-1679 Draft CPG for FDA Employees & Industry on Blood Donor Incent *
00N-1269 Labeling for human prescription drug/Biologic Products *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00N-1625 Rescission of Substantially Equivalent Decisions & Rescissio *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to *
01P-0003 Application for Exemption Laser Products Performance Standar *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0152 Determine that Neurontin capsules was no withdrawn of safety *

90N-0361 Food Labeling, Declaration of Ingredients

C 1034 Doris M Quist Vol#: 33

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

C 4295 Starshine Vol#: 136

C 4296 Ms. Marilyne Masino Vol#: 136

C 4297 Ms. Lois M. Ruffner Vol#: 136

C 4298 Robin Hahn Vol#: 136

C 4299 Margaret Lamanna Vol#: 136

C 4300 Kelly Bradford Vol#: 136

C 4301 Brenda Kaye Finch-Whitlock Vol#: 136

C 4302 Michelle Mack Vol#: 136

C 4303 Dettef Schlempy Vol#: 136

C 4304 David G. Vol#: 136

C 4305 Roger Hallsten Vol#: 136

C 4306 G. Cubrllo Vol#: 136

C 4307 Natalie M. Diehl Vol#: 136

C 4308 Mena Maury McShan Vol#: 136

C 4309 Jena Barretta Vol#: 136

C 4310 Marilyn Davis Vol#: 136

C 4311 Doreen Adams Vol#: 136

C 4312 Patricia Cachopo Vol#: 136

C 4313 William Coleman Vol#: 136

EMC 1568 Deborah Lyman Vol#: 136

EMC 1569 Alison Kirshner Vol#: 136

EMC 1570 Devon & Andrea Augade Vol#: 136

EMC 1571 Carla D'Amico Phillips, RN Vol#: 136

EMC 1572 pmcgaugh Vol#: 136

EMC 1573 D. Tholin Vol#: 136

EMC 1574 Chris Larsen Vol#: 136

EMC 1575 Barbara Perez Vol#: 136

EMC 1576 Dr. Susan J. Feingold Vol#: 136

EMC 1577 Melanie Parker Vol#: 136

EMC 1578 Richard & Denise Degolyer Vol#: 136

EMC 1579 Jane Wells Vol#: 136

EMC 1580 Robert Puca Vol#: 136

EMC 1581 Rachel Galbicka Vol#: 136

EMC 1582 Stacy & Gayle Vol#: 136

EMC 1583 Tara Charkowski Vol#: 136

EMC 1584 Nancy McCarron Vol#: 136

EMC 1585 Melissa McTague & Family Vol#: 136

EMC 1586 Harley J. Shelley Vol#: 136

EMC 1587 Linda de Sota Vol#: 136

00D-1598 Voluntary Labeling for Bioengineered Foods

C 642 Ria Riondo Vol#: 78

C 643 Bruce Milone Vol#: 78

C 644 Susan Linnell Vol#: 78

C 645 L. Lotts Vol#: 78

C 646 C.H. Casson Vol#: 78

C 647 Steven Highsburger Vol#: 78

C 648 Michelle Vogler Vol#: 78

C 649 Ray F. Anderson Vol#: 78

C 650 Bernice Palqmbo Vol#: 78

C 651 Melody Lewis Kane Vol#: 78

C 652 Scarlet L. Kinney Vol#: 78

C 653 Judith Leighton Vol#: 78

C 654 Belelei Lennce Vol#: 78

C 655 Jon Robert Eberle Vol#: 78

C 656 Claudia Keisn Vol#: 78

C 657 John R. Anderson Vol#: 78

C 658 Peter G. Crane Vol#: 78

C 659 Byron D. Gray et al. Vol#: 78

C 660 R. Pappas Vol#: 78

C 661 Lauren DeMaris Vol#: 78

C 662 Pat Vol#: 78

C 663 Gary T. Nagasawa Vol#: 78

C 664 Margaret P. Bartenhagen Vol#: 78

C 665 Tom Clark Vol#: 78

C 666 Margaret L. Meiser Vol#: 78

C 667 Jack & Kathie Barbett Vol#: 78

C 668 Paul W. Jones Vol#: 78

EC 252 Blue Hill Food Coop Vol#: 78

EC 253 The Campaign Vol#: 78

EC 254 Ms. rhonda mankin Vol#: 78

EC 255 Oklahoma State University Vol#: 78

EC 256 Seminis Vegetable Seeds Vol#: 78

EC 257 self Vol#: 78

EC 258 Mrs. Rose Danon Vol#: 78

EC 259 Retired Vol#: 78

EC 260 Mrs. sharon bennett Vol#: 78

EC 261 Mrs. Sharee Berman Vol#: 78

EC 262 Mrs. Chantelle Carlson Vol#: 78

EC 263 International Certification Services, In Vol#: 78

EC 264 Ms. Denise Brennan Vol#: 78

EC 265 Ms. linda price Vol#: 78

EC 266 Ms. Alla Blanca-White Vol#: 78

EC 267 Ms. Melanie Hawkins Vol#: 78

EC 268 Ms. Rachelle Rojany Vol#: 78

EC 269 ESCHOL Enterprises Vol#: 78

00D-1618 Blood collection/persons with Hereditary Hemochromatosis

C 4 America's Blood Centers Vol#: 1

C 5 American Red Cross Vol#: 1

00D-1679 Draft CPG for FDA Employees & Industry on Blood Donor Incent

C 5 Katherine M Marinos Vol#: 1

C 6 Frances Pratt Vol#: 1

C 7 MS Vallely Reg Blood Center Vol#: 1

C 8 American Red Cross Vol#: 1

C 9 Central Blood Bank/LifeSource Bld Ser Vol#: 1

C 10 NY Blood Center Vol#: 1

C 11 Cmty Blood Bank Vol#: 1

C 12 American Assn of Blood Banks Vol#: 1

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

C 14 Boca Raton Psychiatric Group, P.A. Vol#: 3

C 15 American Medical Association Vol#: 3

C 16 Medical Economics Co. Vol#: 3

C 17 Merck & Co., Inc. Vol#: 3

C 18 Schwarz Pharma, Inc. Vol#: 3

C 19 Wyeth-Ayerst Labs. Vol#: 3

C 20 Alcon Research LTD. Vol#: 3

C 21 American Society of Health-System Pharma Vol#: 3

C 22 IDSA, Infectious Diseases Society of Ame Vol#: 3

C 23 DHHS/PHS/FDA Vol#: 3

C 24 DuPont Pharmaceuticals Co. Vol#: 3

C 25 Physician's Folio-Pharma, Inc. Vol#: 3

C 26 NACDS, National Assn. of Chain Drug Stor Vol#: 3

C 27 Baxter Healthcare Corp. Vol#: 3

C 28 Mr. Milton Lev Vol#: 3

C 29 Jay S. Cohen, M.D. Vol#: 3

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 262 Janie Brown Vol#: 31

C 263 Brendan J. Curtin Vol#: 31

C 264 Joanne Fuerst Vol#: 31

C 265 David M. Gladstone Vol#: 31

C 266 Adam Reeve Vol#: 31

C 267 Janyce Halligan Vol#: 31

C 268 Florence E. Oehl Vol#: 31

C 269 Claire Pestak Vol#: 31

C 270 Aja Myers Taylor Vol#: 31

C 271 Heidi Grant Vol#: 31

C 272 Heather Griffin Vol#: 31

C 273 Toni Crowdy Vol#: 31

C 274 Tom Stewart Vol#: 31

C 275 Keren Cabot Vol#: 31

C 276 Joyann Miler Vol#: 31

C 277 John A. Watson Vol#: 31

C 278 LaRue Christie Vol#: 31

C 279 Natalie Dobie Vol#: 31

C 280 Shauna L. Janeway Vol#: 31

C 281 Jennifer Y. McDonald Vol#: 31

C 282 Paul M. Lappen Vol#: 31

C 283 Barbara Murray-Lane Vol#: 31

C 284 Dolores Dukes Vol#: 31

C 285 Sister Irene Mary McDonnell Vol#: 31

C 286 Kathleen Kluthe Vol#: 31

C 287 Mr. & Mrs. Leslie Gavigan Vol#: 31

C 288 Ms. Janet R. Baltes Vol#: 31

C 289 Kate Goldberg Vol#: 31

C 290 Susan Bohannon Vol#: 31

C 291 Karen Swift Vol#: 31

C 292 Marvin McKenza Vol#: 31

C 293 Shannon Mooney Vol#: 31

C 294 Lisa Seepaul Vol#: 31

C 295 John Russell Vol#: 31

C 296 Nance L. Crow Vol#: 31

C 297 Allen Coon Vol#: 31

C 298 Kristen Barney Vol#: 31

C 299 Sara Hutchinson Vol#: 31

C 300 Lori Lash Vol#: 31

C 301 Jinlen Silva Vol#: 31

C 302 Carolyn P. Shaw Vol#: 31

C 303 Janet Smith Vol#: 31

C 304 Mrs. M. Sweeney Vol#: 31

C 305 Sarah Clayton Kelly Vol#: 31

C 306 Alice W. Douglas Vol#: 31

C 307 Joyce Henderson Vol#: 31

C 308 Paul James Vol#: 31

C 309 Jacob S. Ware Vol#: 31

C 310 Perry R. Wilkes Vol#: 31

C 311 Aaron Bower Vol#: 31

C 312 Kim Gleason Vol#: 31

C 313 Hershel Weiss Vol#: 31

C 314 Carolyn Mead Vol#: 31

C 315 Nancy S. Haynes Vol#: 31

C 316 Ramona Reid Vol#: 31

C 317 Jane R. Bentley Vol#: 31

C 318 Zehra Hutton Vol#: 31

C 319 Scott Jackson Vol#: 31

C 320 Linda Stanton Vol#: 31

C 321 Phoenix Forrester Vol#: 31

C 322 Marshall Kovitz Vol#: 31

EC 157 Ms. Denise Brennan Vol#: 23

EC 158 Mr. Mark Thomas Vol#: 23

EC 159 Ms. Alla Blanca-White Vol#: 23

EC 160 Beckman Coulter Inc. Vol#: 23

EC 161 Ms. Jennifer Silvestri Vol#: 23

EC 162 Ms. Franki Jewell Vol#: 23

EC 163 none Vol#: 23

EC 164 Ms. Gail Morris Vol#: 23

EC 165 self Vol#: 23

EC 166 Ms. Judy Kowalczyk Vol#: 23

EC 167 Mr. James Joseph Vol#: 23

EC 168 None Vol#: 23

EC 169 U.S. Citizen Vol#: 23

EC 170 Ms. Daniel STokman Vol#: 23

EC 171 Mr. Cody Wheeler Vol#: 23

EC 172 Citizens for Bio & Cultural Diversity Vol#: 23

EMC 973 Virginia Todd Vol#: 30

EMC 974 Fred Fassberger Vol#: 30

EMC 975 Fred Fassberger Vol#: 30

EMC 976 M. B. Shahmehri Vol#: 30

EMC 977 Jamie Fogle Vol#: 30

EMC 978 Aajonus Vonderplanitz Vol#: 30

EMC 979 Margaret Mahoney Vol#: 30

EMC 980 Susanna King Vol#: 30

EMC 981 Susie Sargent Vol#: 30

EMC 982 Brad Allen Vol#: 30

EMC 983 D R Vol#: 30

EMC 984 D R Vol#: 30

EMC 985 Beth Hanley Vol#: 30

EMC 986 Beth Hanley Vol#: 30

EMC 987 Dan & Julie Brook Vol#: 30

EMC 988 Alistair Jackson Vol#: 30

EMC 989 Martin Hipple Vol#: 30

EMC 990 Meg Arnold Vol#: 30

EMC 991 Sharon Krawczyk Vol#: 30

EMC 992 Sharon Krawczyk Vol#: 30

EMC 993 John W. Hillman Vol#: 30

EMC 994 Curt Larson Vol#: 30

EMC 995 Scott Crawford Vol#: 30

EMC 996 Terry Le Jeune Vol#: 30

EMC 997 Bill Lord Vol#: 30

EMC 998 Adam Hancock Vol#: 30

EMC 999 Adam Hancock Vol#: 30

EMC 1000 Alan R. Seid Vol#: 30

EMC 1001 Daniel Paduano Vol#: 31

EMC 1002 Linsey Hudson Vol#: 31

EMC 1003 Linsey Hudson Vol#: 31

EMC 1004 Barry Nelson Watson Vol#: 31

EMC 1005 Joanne Baek Vol#: 31

EMC 1006 Joanne Baek Vol#: 31

EMC 1007 Colin Gary Dolinar Park Vol#:

EMC 1008 Ethan Hodek Vol#: 31

EMC 1009 Tony Samford Vol#: 31

EMC 1010 David F. Darin Vol#: 31

EMC 1011 Don Smith Vol#: 31

EMC 1012 Lura Trossello Vol#: 31

EMC 1013 Lura Trossello Vol#: 31

EMC 1014 Robin Hessey Vol#: 31

EMC 1015 Aimee Waggoner Vol#: 31

EMC 1016 Anna Crosskill Vol#: 31

EMC 1017 True Laugh Vol#: 31

EMC 1018 Carol Stevenson Vol#: 31

EMC 1019 Candice Cooper-Greinke Vol#: 31

EMC 1020 Nita Alvarez Vol#: 31

EMC 1021 Stephanie Mertens Vol#: 31

EMC 1022 Chris Stevens Vol#: 31

EMC 1023 Devan Miller Vol#: 31

EMC 1024 Heather Allen Vol#: 31

EMC 1025 Jessica Robin Leach Vol#: 31

EMC 1026 Alicia Meredith Vol#: 31

EMC 1027 Alicia Meredith Vol#: 31

EMC 1028 Marjorie Myers Vol#: 31

EMC 1029 Benjamin Evans Vol#: 31

EMC 1030 Donald Merlin Vol#: 31

EMC 1031 Brian Linde Vol#: 31

EMC 1032 Lauren Pilar Cliggitt Vol#: 31

EMC 1033 Mrs. Laurie R. Shows Vol#: 31

EMC 1034 Robert Pandolfo Vol#: 31

EMC 1035 Annalee Letchinger Vol#: 31

EMC 1036 Jennifer Steiger Vol#: 31

EMC 1037 Bob Posey Vol#: 31

EMC 1038 Robert Posey Vol#: 31

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 181 American Association of Swine Veterinari Vol#: 26

00N-1625 Rescission of Substantially Equivalent Decisions & Rescissio

C 2 Zimmer Inc Vol#: 1

C 3 Arrow International Vol#: 1

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

C 9020 Barbara Masin Vol#: 721

C 9021 Joseph Mendelson III Vol#: 721

C 9022 Jean Chatzky Vol#: 721

C 9023 Kerry Canfield Vol#: 721

C 9024 Mary McKinney Vol#: 721

C 9025 Martha H Blackwelder Vol#: 721

C 9026 Barry Brown Vol#: 721

C 9027 Jeff Chioni Vol#: 721

C 9028 J Magic Black-Ferguson Vol#: 721

C 9029 Deborah Norton Vol#: 721

C 9030 Lisa Molitor Vol#: 721

C 9031 Chester Little Vol#: 721

C 9032 Nailer Tretzen Vol#: 721

C 9033 Somya Gutshall Vol#: 721

C 9034 Larry Cartney Vol#: 721

C 9035 Gary Hawkins Vol#: 721

C 9036 R Guzzman Vol#: 721

C 9037 Yve Guthe Vol#: 721

C 9038 Lee McClellan Vol#: 721

C 9039 Mary Dudderary Vol#: 721

C 9040 Maureen Hayden Vol#: 721

C 9041 Christopher Zwkowski Vol#: 721

C 9042 Albani Frank Vol#: 721

C 9043 Sharon Leahy Vol#: 721

C 9044 Cathy Kerr Vol#: 721

C 9045 Janey Bochart Vol#: 721

C 9046 Stacy D Nararro Vol#: 721

C 9047 Erik Gillard Vol#: 721

C 9048 Bertha Mertens Vol#: 721

C 9049 Gina Gruwell Vol#: 721

C 9050 Shawn & Brian Lloyd Vol#: 721

C 9051 Shyela Pecorelli Vol#: 721

C 9052 Gert Gustedt Vol#: 721

C 9053 Mrs J T Schregardus Vol#: 721

C 9054 Marcia Mills Vol#: 721

C 9055 James Desnoyers Vol#: 721

C 9056 Landon Godfrey Vol#: 721

C 9057 Querida Gonzalez Vol#: 721

C 9058 Jayne Larrassey Vol#: 721

C 9059 Andrew J Nugent Vol#: 721

C 9060 Donna L Young Vol#: 721

C 9061 David T Curl Vol#: 721

C 9062 Amy Jester Vol#: 721

C 9063 Joanie Papadopoulou Vol#: 721

C 9064 Kathryn Stinberg Vol#: 721

C 9065 Linda McDonald Vol#: 721

C 9066 Melissa Richmond Vol#: 721

C 9067 David Wehrer Vol#: 721

C 9068 Michelle Thompson Vol#: 721

C 9069 Lucille Roden Vol#: 721

C 9070 J Kitson Vol#: 721

C 9071 Jeff Chiodi Vol#: 721

C 9072 Michelle Pappachriston Vol#: 721

C 9073 Lisa Cat Vol#: 721

C 9074 Cynthea Paul Vol#: 721

C 9075 Annice Muhammad Vol#: 721

C 9076 Erica Tjelta Vol#: 721

C 9077 Jill Grahek Vol#: 721

C 9078 Jennifer Gillmor Vol#: 721

C 9079 Kathryn Leipelt Vol#: 721

C 9080 Addilade Windsor Vol#: 721

C 9081 Maria Brown Vol#: 721

C 9082 Toni Murray Vol#: 721

C 9083 Jennifer O'Brien Vol#: 721

C 9084 Jeff Chiodi Vol#: 721

C 9085 Kathryn Green Vol#: 721

C 9086 Ocawale Ajayi Vol#: 721

C 9087 John Starbuck Vol#: 721

C 9088 Gregory Pensiero Vol#: 721

C 9089 Sue Denton Vol#: 721

C 9090 Art Jessee Vol#: 721

C 9091 Ashiya Dagoo Vol#: 721

C 9092 Wanda Myers Vol#: 721

C 9093 Loreta D Pritchard Vol#: 721

C 9094 Caroline Drader Vol#: 721

C 9095 Charlene Payne Vol#: 721

C 9096 No name Vol#: 721

C 9097 Becca Rose Vol#: 721

C 9098 R L Dermond Vol#: 721

C 9099 Rita Hamel Vol#: 721

C 9100 M L Morris Vol#: 721

C 9101 K Spas Vol#: 721

C 9102 M O Williams Vol#: 721

C 9103 Andres Blumberg Vol#: 721

C 9104 G & M L Wickstead Vol#: 721

C 9105 John P Thomas Vol#: 722

C 9106 David Wallace Vol#: 722

C 9107 Sonya Palmer Vol#: 722

C 9108 Maria Lynn Therese Vol#: 722

C 9109 Caorle Betan Vol#: 722

C 9110 Marilyn Boteler Vol#: 722

C 9111 Robin B Sweet Vol#: 722

C 9112 Inez Diamond Vol#: 722

C 9113 Sara Melnick Vol#: 722

C 9114 Ron Greeb Vol#: 722

C 9115 Jean Shephard Vol#: 722

C 9116 Patricia M McPhee Vol#: 722

C 9117 Evelyn M Dobson Vol#: 722

C 9118 Joyce W Brown Vol#: 722

C 9119 J W Lagler Vol#: 722

C 9120 Richard & Gloria Whitney Vol#: 722

C 9121 Akim Ndlovu Vol#: 722

C 9122 Paola Moreno Vol#: 722

C 9123 Lissette Piepenburg Vol#: 722

C 9124 A A Haas Vol#: 722

C 9125 Peter M Hlinka Vol#: 722

C 9126 Virginia Hornbeck Vol#: 722

C 9127 Pauline Marceline Vol#: 722

C 9128 J insui Giehl Vol#: 722

C 9129 Ron Nowicki Vol#: 722

C 9130 R Martin Vol#: 722

C 9131 Florence Assalit Vol#: 722

C 9132 Barbara M Foley Vol#: 722

C 9133 M Radojkour Vol#: 722

C 9134 Ray Neff Vol#: 722

C 9135 Lou Glorie Vol#: 722

C 9136 Margaret W Funselt Vol#: 722

C 9137 T Bacchos Vol#: 722

C 9138 Jennifer Lazo Vol#: 722

C 9139 Jeff Robbins Vol#: 722

C 9140 Nena Peltin Vol#: 722

C 9141 Kathleen L Orem Vol#: 721

C 9142 Miriam Riter Vol#: 722

C 9143 Peter Bablz Vol#: 722

C 9144 Shontisha Crews Vol#: 722

C 9145 Kim Jones Vol#: 722

C 9146 Paul Luehrmann Vol#: 722

C 9147 Susan Gallegos Vol#: 722

C 9148 Fernand Pascal Vol#: 722

C 9149 O J Lumphrey Vol#: 722

C 9150 Candace Cobb Vol#: 722

C 9151 Daniel Lundberg Vol#: 722

C 9152 Sarah Autumn Patterson Vol#: 722

C 9153 Mrs Gene Kridler Vol#: 722

C 9154 Christine Ratzken Vol#: 722

C 9155 Johnstion Merino Vol#: 722

C 9156 Mike Balkan Vol#: 722

C 9157 Philip Incao Vol#: 722

C 9158 M Wray Vol#: 722

C 9159 Anthony Cress Vol#: 722

C 9160 Beth McCuiston Vol#: 722

C 9161 Elizabeth Krakauer Vol#: 722

C 9162 Liesa Hart Vol#: 722

C 9163 Deborah McKay Vol#: 722

C 9164 Elan Rae Vol#: 722

C 9165 Scott Hamington Vol#: 722

C 9166 Mildred T Redon Vol#: 722

C 9167 Jenna E Blakey Vol#: 722

01H-0065 Civil Money Penalty for First Check Home Drug Test Decives

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to

EC 1 Dartmouth Hitchcock Medical Center Vol#: 1

01P-0003 Application for Exemption Laser Products Performance Standar

LET 1 DRS Technologies Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 24 Edward F. & Alice F. Rivard Vol#: 3

C 25 Arlene Barron, R.N. Vol#: 3

01P-0152 Determine that Neurontin capsules was no withdrawn of safety

ACK 1 HFA-305 Vol#: 1

CP 1 Aptex Crop Vol#: 1