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 June 18, 2001

TABLE OF CONTENTS

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97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC *
99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1269 Labeling for human prescription drug/Biologic Products *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00N-1665 Consumer Roundtable; Notice of Meeting *
01N-0078 Assessment of Physician & Patient Attitudes Toward Direct-to *
01N-0174 Agency Information Collection Recall Regulations *
01N-0205 Applications for FDA Approval to Market a New Drug *
01N-0256 Use of Opiate Analgesics in Various Patient Population inclu *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0272 Permit mfrs. to remove intended use statement from box label *

83V-0228 Laser systems DEV C-3

EXP 5 Space Center Vol#: 1

85V-0239 Variance re laser light show for laser Dream Machine MOD1

VRA 12 HFZ-340 to Laser Dreams Vol#: 1

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

LET 7530 Pharmanex LLC Vol#: 57

LET 7531 Pharmanex LLC Vol#: 57

LET 7532 Pharmanex LLC Vol#: 57

LET 7533 Pharmanex LLC Vol#: 57

LET 7534 Pharmanex LLC Vol#: 57

LET 7535 Pharmanex LLC Vol#: 57

LET 7536 Pharmanex LLC Vol#: 57

LET 7537 Pharmanex LLC Vol#: 57

LET 7538 Pharmanex LLC Vol#: 57

LET 7539 Pharmanex LLC Vol#: 57

LET 7540 Pharmanex LLC Vol#: 57

LET 7541 Pharmanex LLC Vol#: 57

LET 7542 Pharmanex LLC Vol#: 57

LET 7543 Pure Encapsulations Inc (Emord & Associt Vol#: 57

LET 7544 L Perrigo Company Vol#: 57

LET 7545 Planetary Formulas Vol#: 57

LET 7546 Mannatech Inc Vol#: 57

LET 7547 Performance Inc Vol#: 57

LET 7548 EFAsense LTD Vol#: 57

LET 7549 Natural Organics Inc Vol#: 57

LET 7550 Natural Organics Inc Vol#: 57

LET 7551 Natural Organics Inc Vol#: 57

LET 7552 Natural Organics Inc Vol#: 57

LET 7553 Natural Organics Inc Vol#: 57

LET 7554 Natural Organics Inc Vol#: 57

LET 7555 Natural Organics Inc Vol#: 57

LET 7556 NOW Foods Vol#: 57

LET 7557 Natural Organics Inc Vol#: 57

LET 7558 Advantage Marketing Inc Vol#: 57

LET 7559 Jarrow Formulas Inc Vol#: 57

LET 7560 Soft Gel Technologies Inc Vol#: 57

LET 7561 Alva-Amco Pharmacal Companies Inc Vol#: 57

LET 7562 Country Life Vol#: 57

LET 7563 O'Donnell Formulas Inc Vol#: 57

LET 7564 Jarrow Formulas Inc Vol#: 57

LET 7565 Jarrow Formulas Inc Vol#: 57

LET 7566 Jarrow Formulas Inc Vol#: 57

LET 7567 Jarrow Formulas Inc Vol#: 57

LET 7568 Country Life Vol#: 57

LET 7569 NBTY Inc Vol#: 57

LET 7570 NBTY Inc Vol#: 57

LET 7571 L Perrigo Company Vol#: 57

LET 7572 Nature's Formulary LLC Vol#: 57

LET 7573 NOW Foods Vol#: 57

LET 7574 NOW Foods Vol#: 57

LET 7575 Natural Organics Inc Vol#: 57

LET 7576 Herb Pharm Vol#: 57

LET 7577 Tsunami Supplemens, Div of CPG Vol#: 57

LET 7578 Optio Health Products Vol#: 57

LET 7579 Herbalife International of American Inc Vol#: 57

LET 7580 Solstice Medicine Company Vol#: 57

LET 7581 Solstice Medicine Company Vol#: 57

LET 7582 Nature's Sunshine Products Inc (Gronek & Vol#: 57

LET 7583 General Vitamin COrp Vol#: 57

LET 7584 General Vitamin COrp Vol#: 57

LET 7585 Solstice Medicine Company Vol#: 57

LET 7586 General Vitamin COrp Vol#: 57

LET 7587 General Vitamin COrp Vol#: 57

LET 7588 Natural Organics Inc Vol#: 57

LET 7589 Natural Organics Inc Vol#: 57

LET 7590 Natural Organics Inc Vol#: 57

LET 7591 Natural Organics Inc Vol#: 57

LET 7592 Natural Organics Inc Vol#: 57

LET 7593 Natural Organics Inc Vol#: 57

LET 7594 Oleomed American, Pharmed Group Corp Vol#: 57

LET 7595 Planetary Formulas Vol#: 57

LET 7596 Planetary Formulas Vol#: 57

LET 7597 NBTY Inc Vol#: 57

LET 7598 NBTY Inc Vol#: 57

LET 7599 NBTY Inc Vol#: 57

LET 7600 American Health Packaging Vol#: 57

LET 7601 American Health Packaging Vol#: 57

LET 7602 American Health Packaging Vol#: 57

LET 7603 Solgar Vitamin & Herb Vol#: 57

LET 7604 Solgar Vitamin & Herb Vol#: 57

LET 7605 Solgar Vitamin & Herb Vol#: 57

LET 7606 FreeLife Vol#: 57

LET 7607 FreeLife Vol#: 57

LET 7608 FreeLife Vol#: 57

LET 7609 FreeLife Vol#: 57

LET 7610 FreeLife Vol#: 57

LET 7611 FreeLife Vol#: 57

LET 7612 FreeLife Vol#: 57

LET 7613 FreeLife Vol#: 57

LET 7614 FreeLife Vol#: 57

LET 7615 FreeLife Vol#: 57

LET 7616 FreeLife Vol#: 57

LET 7617 FreeLife Vol#: 57

LET 7618 FreeLife Vol#: 57

LET 7619 FreeLife Vol#: 57

LET 7620 FreeLife Vol#: 57

LET 7621 FreeLife Vol#: 57

LET 7622 FreeLife Vol#: 57

LET 7623 FreeLife Vol#: 57

LET 7624 FreeLife Vol#: 57

LET 7625 FreeLife Vol#: 57

LET 7626 FreeLife Vol#: 57

LET 7627 FreeLife Vol#: 57

LET 7628 FreeLife Vol#: 57

LET 7629 FreeLife Vol#: 57

LET 7630 FreeLife Vol#: 57

LET 7631 FreeLife Vol#: 57

LET 7632 FreeLife Vol#: 57

LET 7633 FreeLife Vol#: 57

LET 7634 Alcon Research Ltd Vol#: 57

LET 7635 Eco Nutrients Inc Vol#: 57

LET 7636 Winning Combination Vol#: 57

LET 7637 Natural Organics Inc Vol#: 57

LET 7638 Natural Organics Inc Vol#: 57

LET 7639 Natural Organics Inc Vol#: 57

LET 7640 Natural Organics Inc Vol#: 57

LET 7641 Natural Organics Inc Vol#: 57

LET 7642 Natural Organics Inc Vol#: 57

LET 7643 New Vision International Holdings Inc Vol#: 57

LET 7644 Country Life Vol#: 57

LET 7645 Country Life Vol#: 57

LET 7646 Amrita Veda (Arent Fox Kintner Plotkin & Vol#: 57

LET 7647 Zhishin LLC Vol#: 57

LET 7648 Zhishin LLC Vol#: 57

LET 7649 Zhishin LLC Vol#: 57

LET 7650 Zhishin LLC Vol#: 57

LET 7651 Zhishin LLC Vol#: 57

LET 7652 Zhishin LLC Vol#: 57

LET 7653 Zhishin LLC Vol#: 57

LET 7654 Zhishin LLC Vol#: 57

LET 7655 The House of Yin Yand Ltd Vol#: 57

LET 7656 The House of Yin Yand Ltd Vol#: 57

LET 7657 The House of Yin Yand Ltd Vol#: 57

LET 7658 Nature's Sunshine Products Inc (Gronek Vol#: 57

LET 7659 Nature's Sunshine Products Inc (Gronek Vol#: 57

LET 7660 Tanaid Inc Vol#: 57

LET 7661 Natural Organics Inc Vol#: 57

LET 7662 Natural Organics Inc Vol#: 57

LET 7663 Natural Organics Inc Vol#: 57

97V-0231 Laser light show

VRA 3 HFZ-340 to Paramount Organization, Inc. Vol#: 1

98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

EC 17 Mr. Steven Schladale Vol#: 3

EC 18 Mrs. Betty Jackson Vol#: 3

EC 19 none Vol#: 3

EC 20 none Vol#: 3

EC 21 Ms. Gaye Wiesner Vol#: 3

EC 22 univera healthcare Vol#: 3

EC 23 Univera Healthcare Vol#: 3

EC 24 Mrs. Selma Becker Vol#: 3

EC 25 Dr. Kathy Warshawsky Vol#: 3

EC 26 Ms. Mary Monahan Vol#: 3

EC 27 Mr. Ray Wagner Vol#: 3

EC 28 Mrs. Kathryn Wooley Vol#: 3

EC 29 SCAN Vol#: 3

99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices

EC 1 Miss Wendy Daniels Vol#: 1

99V-1717 Laser Light Show

VRA 2 HFZ-340 to Laser Show Design, Inc. Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 6102 Sean Haworth Vol#: 312

EMC 6103 Elizabeth Clodfelter Vol#: 312

EMC 6104 Elizabeth Clodfelter Vol#: 312

EMC 6105 Hope Stanger Vol#: 312

EMC 6106 Miss Toni Alazraki Vol#: 312

EMC 6107 Les Cole, M.D. Vol#: 312

EMC 6108 unsigned Vol#: 312

EMC 6109 Portia S. Wadsworth Vol#: 312

EMC 6110 Kathleen Beasley Vol#: 312

EMC 6111 Patti Steurer and David Fuerstenau Vol#: 312

EMC 6112 Anthony Stackpoole, Nutraceutical Consul Vol#: 312

EMC 6113 number not used Vol#: 312

EMC 6114 Christine L. Sandy Vol#: 312

EMC 6115 Karen Erikson Vol#: 312

EMC 6116 Hal Goldstein Vol#: 312

EMC 6117 unsigned Vol#: 312

EMC 6118 Oshana Biondi Vol#: 312

EMC 6119 Chisick Family Farm Vol#: 312

EMC 6120 Elen Clulow Vol#: 312

EMC 6121 Mark Cutter, CTO Vol#: 312

EMC 6122 Jim Fouratt Vol#: 312

EMC 6123 William McMullin Vol#: 312

EMC 6124 Edgar and Teresa Shyuan Vol#: 312

EMC 6125 John Murray Vol#: 312

EMC 6126 Sarah Nason Vol#: 312

EMC 6127 Suseen Banks Vol#: 312

EMC 6128 Rhonda Stieglitz Vol#: 312

EMC 6129 Tobin and Linda Crawford Vol#: 312

EMC 6130 Gretchen Altabef Vol#: 312

EMC 6131 Kris Dorasami Vol#: 312

EMC 6132 Rebecca Griffiths Vol#: 312

EMC 6133 unsigned Vol#: 312

EMC 6134 B. Sashaw Vol#: 312

EMC 6135 Baljinder Badyal Vol#: 312

EMC 6136 Richard McDonald Vol#: 312

EMC 6137 Philip L Notermann Vol#: 312

EMC 6138 unsigned Vol#: 312

EMC 6139 Sara Camp Vol#: 312

EMC 6140 Nancy Brown Vol#: 312

EMC 6141 Nancy Brown Vol#: 312

EMC 6142 Westview Farm Bed and Breakfast Vol#: 312

EMC 6143 Colleen Novosielski Vol#: 312

EMC 6144 Lauren Darges Vol#: 312

EMC 6145 John Macey Vol#: 312

EMC 6146 Nathaniel Levin Vol#: 312

EMC 6147 Cynthia Pettit Vol#: 312

EMC 6148 Mary McLellan Vol#: 312

EMC 6149 Roy Padilla Vol#: 312

EMC 6150 Laura Culp Vol#: 312

EMC 6151 unsigned Vol#: 312

EMC 6152 Jessica Harris Vol#: 312

EMC 6153 Brad Frank Vol#: 312

EMC 6154 Genevieve Vierling Vol#: 312

EMC 6155 Dorothy Hahn Vol#: 312

EMC 6156 Capt. Roy L. Pickett, USMC Vol#: 312

EMC 6157 Andrew Jolly Vol#: 312

EMC 6158 unsigned Vol#: 312

EMC 6159 unsigned Vol#: 312

EMC 6160 Nancy H. Omaha Boy, PhD Vol#: 312

EMC 6161 Beverly Gundlach Vol#: 312

EMC 6162 unsigned Vol#: 312

EMC 6163 Scott P. Wilson Vol#: 312

EMC 6164 Megan Culler Vol#: 312

EMC 6165 Gail Odegaard Vol#: 312

EMC 6166 Stephanie Weaver Vol#: 312

EMC 6167 Daniella Chace Vol#: 312

EMC 6168 Gary Schoenberg Vol#: 312

EMC 6169 unsigned Vol#: 312

EMC 6170 Talitha Thalya Vol#: 312

EMC 6171 Dr. Mindy Barkins, DC, CCN Vol#: 312

EMC 6172 Nadine Bauer Vol#: 312

EMC 6173 unsigned Vol#: 312

EMC 6174 Karla Christensen Vol#: 312

EMC 6175 Martha DeSisto Vol#: 312

EMC 6176 T.D. Harvey Vol#: 312

EMC 6177 Ed Fasanella Vol#: 312

EMC 6178 Elizabeth Kukely Vol#: 312

EMC 6179 Lindea Bowe Kirschner Vol#: 312

EMC 6180 Helen Moore Vol#: 312

EMC 6181 Tim Wargo, MD Vol#: 312

EMC 6182 Greg Yaroslow Vol#: 312

EMC 6183 Jan Ballard Vol#: 312

EMC 6184 Deborah Kraft Vol#: 312

EMC 6185 Rich Sims Vol#: 312

EMC 6186 Barry Snitkin Vol#: 312

EMC 6187 Charles Cranford Vol#: 312

EMC 6188 Lion Goodman Vol#: 312

EMC 6189 John Stayton Vol#: 312

EMC 6190 Sarah and Darren Volkay Vol#: 312

EMC 6191 Curt Hamre/Anne Dinshah Vol#: 312

EMC 6192 Laura Silber Vol#: 312

EMC 6193 Douglas and Margaret Bradley Vol#: 312

EMC 6194 John Kroonen Vol#: 312

EMC 6195 David Shapiro Vol#: 312

EMC 6196 Shirley Baker Vol#: 312

EMC 6197 Gregory Wieting Vol#: 312

EMC 6198 Wendy Richardson Vol#: 312

EMC 6199 Wendy Richardson Vol#: 312

EMC 6200 Lee Shinefield Vol#: 312

EMC 6201 Mary Kulakowski Vol#: 313

EMC 6202 Peter Stark Vol#: 313

EMC 6203 Gregory Babior Vol#: 313

EMC 6204 John Neville Vol#: 313

EMC 6205 Virginia Irvin Vol#: 313

EMC 6206 Panther Wilde Vol#: 313

EMC 6207 Andrew Lumbar Vol#: 313

EMC 6208 Michael Hathaway Vol#: 313

EMC 6209 Roy Eaton Vol#: 313

EMC 6210 Ginger Gray Vol#: 313

EMC 6211 Jonathan Ratner Vol#: 313

EMC 6212 Linda Hines Vol#: 313

EMC 6213 Jennifer Catania Vol#: 313

EMC 6214 Gary J. Proulx Vol#: 313

EMC 6215 Harney Vol#: 313

EMC 6216 Christine Aquilino Vol#: 313

EMC 6217 Bob Segal Vol#: 313

EMC 6218 John Delevoryas Vol#: 313

EMC 6219 Carole Currie Vol#: 313

EMC 6220 Carole Currie Vol#: 313

EMC 6221 Zita A. Lynn Vol#: 313

EMC 6222 unsigned Vol#: 313

EMC 6223 unsigned Vol#: 313

EMC 6224 Nancy Willbanks Vol#: 313

EMC 6225 Tristan Hilton Brown Vol#: 313

EMC 6226 Julia Weinmann Vol#: 313

EMC 6227 Lucia Rich Vol#: 313

EMC 6228 Janice Reinhart Vol#: 313

EMC 6229 number not used Vol#: 313

EMC 6230 M. Abernathy Vol#: 313

EMC 6231 Andrea Massey Vol#: 313

EMC 6232 Michael Colpo Vol#: 313

EMC 6233 Sesha Ward Vol#: 313

EMC 6234 unsigned Vol#: 313

EMC 6235 Jonathan Lipman Vol#: 313

EMC 6236 Jennifer Barricklow Vol#: 313

EMC 6237 Walter Stokes Vol#: 313

EMC 6238 Carol Logan Vol#: 313

EMC 6239 Connie Ciekanski Vol#: 313

EMC 6240 Robert Kirschenbaum Vol#: 313

EMC 6241 Sue Goodell Vol#: 313

EMC 6242 James Servais Vol#: 313

EMC 6243 Judy Dragon Vol#: 313

EMC 6244 Gerald Martin Vol#: 313

EMC 6245 unsigned Vol#: 313

EMC 6246 Noah Schechtman Vol#: 313

EMC 6247 unsigned Vol#: 313

EMC 6248 Monty H Congdon Vol#: 313

EMC 6249 Barbara Keeler Vol#: 313

EMC 6250 Gabrielle Laney Vol#: 313

EMC 6251 Mrs. Patricia M. Rich Vol#: 313

EMC 6252 Robert Schlesinger Vol#: 313

EMC 6253 Susan Fantz Vol#: 313

EMC 6254 Petra Sundheim Vol#: 313

EMC 6255 Richard Heinberg Vol#: 313

EMC 6256 Ruth Broyde-Sharone Vol#: 313

EMC 6257 unsigned Vol#: 313

EMC 6258 Rosemary Whitt Vol#: 313

EMC 6259 LaRue Martin Vol#: 313

EMC 6260 LaRue Martin Vol#: 313

EMC 6261 Chris Korrow Vol#: 313

EMC 6262 Constantin Parvulescu, primas Vol#: 313

EMC 6263 Isaiah King Solomon Vol#: 313

EMC 6264 Kylie Willows Vol#: 313

EMC 6265 Kathleen Luebbert Vol#: 313

EMC 6266 Kay Snow-Davis Vol#: 313

EMC 6267 unsigned Vol#: 313

EMC 6268 Philip Magnier Vol#: 313

EMC 6269 Robin Brooks Vol#: 313

EMC 6270 James Goldstein Vol#: 313

EMC 6271 Linda McKee Vol#: 313

EMC 6272 unsigned Vol#: 313

EMC 6273 Genny Genevich Vol#: 313

EMC 6274 Deborah S. McLeod Vol#: 313

EMC 6275 Susan Solleder Vol#: 313

EMC 6276 Batya Bauman Vol#: 313

EMC 6277 Gina Shamey Panzieri Vol#: 313

EMC 6278 Alexander Ruzicka Vol#: 313

EMC 6279 Pamela Price Mitchem Vol#: 313

EMC 6280 Linda Ryan Vol#: 313

EMC 6281 Kurt Buehler Vol#: 313

EMC 6282 Lois Blackwell Vol#: 313

EMC 6283 Sarah Whitman Vol#: 313

EMC 6284 Jennifer Nall Vol#: 313

EMC 6285 Mary de La Valette Vol#: 313

EMC 6286 Michelle Law Vol#: 313

EMC 6287 Jeffrey Mans Vol#: 313

EMC 6288 unsigned Vol#: 313

EMC 6289 number not used Vol#: 313

EMC 6290 Aajonus Vonderplanitz Vol#: 313

EMC 6291 Barbara Wascom Vol#: 313

EMC 6292 Thomas Joseph Lydon, Jr. Vol#: 313

EMC 6293 Zlatko Batistich Vol#: 313

EMC 6294 L. Mackenzie Cohen Vol#: 313

EMC 6295 Kathryn Dixon Vol#: 313

EMC 6296 unsigned Vol#: 313

EMC 6297 Andrew Tarr Vol#: 313

EMC 6298 number not used Vol#: 313

EMC 6299 Lelania Avila Vol#: 313

EMC 6300 Eden Robertson Vol#: 313

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

EC 19 Kaiser Permanente Vol#: 4

EC 20 Ohio State Medical Association member Vol#: 4

EC 21 Dr. marc rosenblatt Vol#: 4

EC 22 3 MDSS/SGSP Vol#: 4

EC 23 North Dakota Board of Pharmacy Vol#: 4

EC 24 Comprehensive Home Holistic Health Care Vol#: 4

EC 25 Dr. marc rosenblatt Vol#: 4

EC 26 Legal Counsel - Wisconsin Pharmacy Exami Vol#: 4

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 4001 Joy De Young Vol#: 218

C 4002 Joseph Anzivino Vol#: 218

C 4003 Sandy Robertson Vol#: 218

C 4004 Ms. Alyce Jordan Vol#: 218

C 4005 Heidi Haines Vol#: 218

C 4006 Amy Nonnermacher Vol#: 218

C 4007 P. Thompson Vol#: 218

C 4008 Doug Maierhafer Vol#: 218

C 4009 Bob Ellquist Vol#: 218

C 4010 Sara Ramel Vol#: 218

C 4011 Deborah Wiggins Vol#: 218

C 4012 Diana Stough Vol#: 218

C 4013 Lynn Chiapella Vol#: 218

C 4014 Michael Campbell, Ph.D. Vol#: 218

C 4015 Michelle Morrison Vol#: 218

C 4016 Jim Lewis Vol#: 218

C 4017 Nimred Omer Vol#: 218

C 4018 Robert E. Lamb Vol#: 218

C 4019 L. Johnson Vol#: 218

C 4020 Lynn Dever Vol#: 218

C 4021 Michael Scudant Vol#: 218

C 4022 Adah E. Trapani Vol#: 218

C 4023 P. Knapp Vol#: 218

C 4024 Susan Burns Vol#: 218

C 4025 Elin Baravsky Vol#: 218

C 4026 Julie Rowan-Zoch Vol#: 218

C 4027 Christina C. Smith Vol#: 218

C 4028 Gloria Estrada Vol#: 218

C 4029 Randy Johnson Vol#: 218

C 4030 Nancy Pettengill Vol#: 218

C 4031 Miriam Kligerman Vol#: 218

C 4032 Maurice Rosenberg Vol#: 218

C 4033 unreadable Vol#: 218

C 4034 Grace Park Vol#: 218

C 4035 Roya Staley Vol#: 218

C 4036 Sherry McLaughlin Vol#: 218

C 4037 Dale Higginsbotham Vol#: 218

C 4038 Jage Goodman Vol#: 218

C 4039 unreadable Vol#: 218

C 4040 Janice Holland Vol#: 218

C 4041 Jon Rademackers Vol#: 218

C 4042 Cosima Krueger Cunningham Vol#: 218

C 4043 Kim Gustatson Vol#: 218

C 4044 Mary E. Copper Vol#: 218

C 4045 Ms. Myrtsie J. Cruz Vol#: 218

C 4046 unreadable Vol#: 218

C 4047 Constance C. Michel Vol#: 218

C 4048 G. Wellman Vol#: 218

C 4049 Caren McCourtney Vol#: 218

C 4050 Linda H. App Vol#: 218

C 4051 Judith Alper Vol#: 218

C 4052 Paul Markavitz Vol#: 218

C 4053 Jon Ellsworth Vol#: 218

C 4054 John Hunt Vol#: 218

C 4055 Natalie Cabrera Vol#: 218

C 4056 J. L. Lakos Vol#: 218

C 4057 Chris Breck Vol#: 218

C 4058 Larecy Vol#: 218

C 4059 Andrew Davis Vol#: 218

C 4060 Lisa B. Evans Vol#: 218

C 4061 Scott Dennis Vol#: 218

C 4062 Mary Darrell Vol#: 218

C 4063 Mrs. Edwin D. Elzings Vol#: 218

C 4064 unreadable Vol#: 218

C 4065 T. Bradley Vol#: 218

C 4066 Chad Bliss Vol#: 218

C 4067 Katryn Jehane Price Vol#: 218

C 4068 Cassandra Saulter Vol#: 218

C 4069 Mrs. Richard A. Gaines Vol#: 218

C 4070 K. MacGibbon Vol#: 218

C 4071 Kay Andrews Vol#: 218

C 4072 Dawn Menken Vol#: 218

C 4073 David Hunter Vol#: 218

C 4074 F. Carey Vol#: 218

C 4075 Anastasia Steften Vol#: 218

C 4076 Lynn Marie Hughes Vol#: 218

C 4077 M. L. Fink Vol#: 218

C 4078 E. Frankish Vol#: 218

C 4079 Irene Haughey Vol#: 218

C 4080 Gloria Hearten Vol#: 218

C 4081 Barbara S. Dague Vol#: 218

C 4082 Susan Hulseman Vol#: 218

C 4083 Isaac Etherington Vol#: 218

C 4084 Carin Houck-Wylie Vol#: 218

C 4085 Nyles Williams Vol#: 218

C 4086 Pieter Bowman Vol#: 218

C 4087 Lisa Bruno Vol#: 218

C 4088 Monika Colton Vol#: 218

C 4089 Carla Kallan Vol#: 218

C 4090 Susan & Jon Wittwer Vol#: 218

C 4091 Craig Rice Vol#: 218

C 4092 Celia Scott Vol#: 218

C 4093 Deborah S. Tilghman Vol#: 218

C 4094 American Bakers Association Vol#: 218

C 4095 Jan Feeler Vol#: 218

C 4096 Wendy DeForest Vol#: 218

C 4097 Clark A. Kerschner Vol#: 218

C 4098 Cynthia G. Huyser Vol#: 218

C 4099 S. Friedman Vol#: 218

C 4100 Phyllis Brooks Vol#: 218

C 4101 Crystal Nicholas Vol#: 219

C 4102 Myra Richards Vol#: 219

C 4103 Lillian Ritger Vol#: 219

C 4104 Mike Rubio Vol#: 219

C 4105 Effie Kuriloff Vol#: 219

C 4106 Damon R. Phillips Vol#: 219

C 4107 Samuel Mix & Kristin Ruger Vol#: 219

C 4108 Paul & Megan Wright Vol#: 219

C 4109 Gloria Estrada Vol#: 219

C 4110 Frank Olsen Vol#: 219

C 4111 Dorothy A. Fraquelli, Ph.D. Vol#: 219

C 4112 Steven Franks Vol#: 219

C 4113 Valinda S. Carroll Vol#: 219

C 4114 Caith R. Wiles Vol#: 219

C 4115 Davina Rubin Vol#: 219

C 4116 24 signatures Vol#: 219

C 4117 Christopher J. Steller Vol#: 219

C 4118 Joshua Goldman Vol#: 219

C 4119 Douglas Conwell Vol#: 219

C 4120 Shakti Pearce Vol#: 219

C 4121 Punya Upadhyaya, Ph.D. Vol#: 219

C 4122 Virginia A. Gilpin Vol#: 219

C 4123 Ms. Lorie Levison Vol#: 219

C 4124 Ralph Perron Vol#: 219

C 4125 Virginia Assoc. for Biological Farming Vol#: 219

C 4126 Alice H. Sievert Vol#: 219

C 4127 Sheila & Lou Incognito Vol#: 219

C 4128 Frances Hartnett Angara Vol#: 219

C 4129 Mark E. Miller Vol#: 219

C 4130 John Bagby Vol#: 219

C 4131 Ned Bittinger Vol#: 219

C 4132 Lani N. Jacobs Vol#: 219

C 4133 David Nolte Vol#: 219

C 4134 John Keith Vol#: 219

C 4135 Rosemary E. O'Brien Vol#: 219

C 4136 Ann Gaba Vol#: 219

C 4137 Randall K. Braden Vol#: 219

C 4138 Ronald Ringsrud Vol#: 219

C 4139 Barbara B. Dreier Vol#: 219

C 4140 Ken Horn Vol#: 219

C 4141 Phyllis Pryor Vol#: 219

C 4142 Richard Swinehart Vol#: 219

C 4143 Lorraine Lamey Vol#: 219

C 4144 Cecile T. Tougas, Ph.D. Vol#: 219

C 4145 Janet R. Borowski Vol#: 219

C 4146 Dr. Debra Giambo Vol#: 219

C 4147 Ann Thek Vol#: 219

C 4148 Diane Opal Vol#: 219

C 4149 Kathleen McNamara Vol#: 219

C 4150 Gerry Griesbaum Vol#: 219

C 4151 Nina Kelso Vol#: 219

C 4152 Lee Ristow Vol#: 219

C 4153 unreadable Vol#: 219

C 4154 Sara Kaetzer Vol#: 219

C 4155 S. LaBelle Vol#: 219

C 4156 Rose Poss Vol#: 219

C 4157 Lynn Olson Vol#: 219

C 4158 Bruce Canghran Vol#: 219

C 4159 Octavia Kincaid Vol#: 219

C 4160 Ann Kalra Vol#: 219

C 4161 Dr. M. Holliday Vol#: 219

C 4162 Valerie L. Michael Vol#: 219

C 4163 Louise P. Milne Vol#: 219

C 4164 Mr. & Mrs. George K. Arnold Vol#: 219

C 4165 James D. Wagner Vol#: 219

C 4166 Tanja Ryden Vol#: 219

C 4167 Beatrice & William Wexler Vol#: 219

C 4168 Mrs. Loretta Ditlow Vol#: 219

C 4169 Adam Stenftenasel Vol#: 219

C 4170 Karen Bernard Vol#: 219

C 4171 Sarah Wolff Vol#: 219

C 4172 David Henry Vol#: 219

C 4173 Tom Sterner Vol#: 219

C 4174 Berkeley Danelski Vol#: 219

C 4175 Gloria Estrada Vol#: 219

C 4176 E. M. McKim Vol#: 219

C 4177 Marcia Berman Vol#: 219

C 4178 Charles McCollum Vol#: 219

C 4179 Home of Integrated Biological Cybernetic Vol#: 219

C 4180 Laura Casey Vol#: 219

C 4181 Chailly Clayton Vol#: 219

C 4182 Clark R. Barefoot Vol#: 219

C 4183 Donna Mansur Vol#: 219

C 4184 M. J. Glastonbury Vol#: 219

C 4185 Vicki Buchanan Vol#: 219

C 4186 Hilary Thomas Vol#: 219

C 4187 Karen Smith Vol#: 219

C 4188 Marnice Wolfe Vol#: 219

C 4189 Alice J. Rawlings Vol#: 219

C 4190 Mr. James D. Wagner Vol#: 219

C 4191 Christine Lee Vol#: 219

C 4192 Gerry Camarata, M.D. Vol#: 219

C 4193 Donald J. Walsh Vol#: 219

C 4194 Tim Miller Vol#: 219

C 4195 unreadable Vol#: 219

C 4196 Zina & Robert Booher Vol#: 219

C 4197 Mark Shone Vol#: 219

C 4198 Pamela J. Barber Vol#: 219

C 4199 Roberta Stewart Vol#: 219

C 4200 Chelsie Laudicina Vol#: 219

C 4201 Betty J. Le Donne Vol#: 219

C 4202 Tappi Squire Vol#: 219

C 4203 Nancy Collentine Vol#: 219

C 4204 Nancy Collentine Vol#: 219

C 4205 Jan Kalzia Vol#: 219

C 4206 Chris Heath Vol#: 219

C 4207 Sally Farrell Vol#: 219

C 4208 Sarah Widercrartz Vol#: 219

C 4209 Mary Carrey Vol#: 219

C 4210 Eleanor Baldwin Vol#: 221

C 4211 Vernise Pelzel Vol#: 221

C 4212 Ginny Lewis Vol#: 221

C 4213 Lisa Richmond & Jonathan Mills Vol#: 221

C 4214 A. J. Travland Vol#: 221

C 4215 Pat Brewster Vol#: 221

C 4216 Patricia Kern Vol#: 221

C 4217 unreadable Vol#: 221

C 4218 Kit Kyle Vol#: 221

C 4219 Mary Hogan Vol#: 221

C 4220 Robert A. Gonzales Vol#: 221

C 4221 Rita Romans Vol#: 221

C 4222 Mary De La Valette Vol#: 221

C 4223 Robin Polishook Vol#: 221

C 4224 Linda Drake Vol#: 221

C 4225 Lily Hail Vol#: 221

C 4226 Andre Smith Vol#: 221

C 4227 Amelia Jones Vol#: 221

C 4228 Renee Lorenz Vol#: 221

C 4229 Ray Wittenmeyer Vol#: 221

C 4230 Z. Zsido Vol#: 221

00N-1665 Consumer Roundtable; Notice of Meeting

EC 18 Ms. Sharon Andrews Vol#: 1

01D-0232 Reprocessing/Reuse of Single-Use Devices for Industry/FDA

EC 1 Number Not Used Vol#: 1

01N-0063 Medical Devices; CGMP Quality System Regulation

N 2 Vol#: 1

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

EC 9 Center for Medical Consumers Vol#: 1

EC 10 Pharmaceutical Research & Manufacturers Vol#: 1

EC 11 RxHealthValue Vol#: 1

EC 12 GlaxoSmithKline Vol#: 1

01N-0154 Color Additive Certification Request and Recordkeeping

EC 2 Not applicable Vol#: 1

01N-0174 Agency Information Collection Recall Regulations

EC 4 Mrs. Michele Dougherty Vol#: 1

01N-0205 Applications for FDA Approval to Market a New Drug

EC 1 S2 Consulting Services, Inc. Vol#: 1

EC 2 Georgetown Memorial Hospital on Disabili Vol#: 1

EC 3 St. Vincent Hospital and HCC Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 1 Number Not Used Vol#: 1

EC 2 Mrs. Patricia Edmonds Vol#: 1

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

C 167 Delia A. Smith Vol#: 7

C 168 Lindsay Bustillos Vol#: 7

C 169 Barbara McCarthy Vol#: 7

01P-0272 Permit mfrs. to remove intended use statement from box label

ACK 1 HFA-305 Vol#: 1

CP 1 Bio-Rad Laboratories Vol#: 1

01V-0118 LPD9000,Q-BeamSeries Q-40(RG)(MC),Q-100G,Q-150G,Q175G,Q500G

VRA 1 HFZ-340 to Silver Lanes Vol#: 1

01V-0138 Q-Beam series for a laser light show and projectors

VRA 1 HFZ-340 to DJ Tony Vol#: 1

01V-0164 Laser Light Show

VRA 1 HFZ-340 to Duck Inn Vol#: 1

01V-0165

VRA 1 HFZ-340 to Greg McNeelly Vol#: 1

01V-0166

VRA 1 HFZ-340 to Sound Connection Vol#: 1

01V-0200

VRA 1 HFZ-340 to National Sound & Lighting Vol#: 1

01V-0273

ACK 1 HFA-305 Vol#: 1

VAR 1 Forum Night Club Inc. Vol#: 1