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 August 9, 2001

TABLE OF CONTENTS

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98N-1038 Irradiation in the production, processing, &handling of food *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1662 Use of Xenotransplantation Products in Humans *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1322 Food Labeling and Allergen Contamination Control *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0343 Metal/Metal Semi-Constrained Hip Joint Prosthesis *
01P-0346 Modify 8/14/01 deadline re: submission & approval of PMA *
98N-1038 Irradiation in the production, processing, &handling of food

C 5332 Mr. Harry Santangelo Vol#: 164

C 5333 Sarah Schwandt Vol#: 164

C 5334 Myra Arendt Vol#: 164

C 5335 Marya Zanders Vol#: 164

C 5336 8 signatures Vol#: 164

C 5337 Ecology Center of Southern California Vol#: 164

C 5338 Yvonne Fraizer Vol#: 164

C 5339 Becky Long Vol#: 164

C 5340 Donna & Maru Wilensky Vol#: 164

C 5341 Paul Mack Vol#: 164

C 5342 Marion Barbour Vol#: 164

C 5343 Mary Bowmen Vol#: 164

C 5344 Elizabeth A. Hall Vol#: 164

C 5345 Mary McCarthy Vol#: 164

C 5346 Fort Salonga Assn., Inc. Vol#: 164

C 5347 Debbie & Francis Desmoulin Vol#: 164

C 5348 Phoebe R. Gilchrist Vol#: 164

C 5349 Isabelle Buonocore Vol#: 164

00D-1598 Voluntary Labeling for Bioengineered Foods

C 6874 Michael Hill Vol#: 421

C 6875 Madonna Brock Vol#: 421

C 6876 Ann Maria Bell Vol#: 421

C 6877 George Lawson Vol#: 421

C 6878 Wayne Forbes Vol#: 421

C 6879 Jackie Willey Vol#: 421

C 6880 Jennifer Kane Vol#: 421

C 6881 Margaret Levy Vol#: 421

C 6882 John Oritz Vol#: 421

C 6883 Renee Weller Vol#: 421

C 6884 Tim Crowley Vol#: 421

C 6885 Jana Corris Vol#: 421

C 6886 Dianel Petkus Vol#: 421

C 6887 Lidia Bertolini Vol#: 421

C 6888 Jane Zimmer Vol#: 421

C 6889 Christina McElroy Vol#: 421

C 6890 Terri Bullert Vol#: 421

C 6891 Dr. Ron Vogel, PhD Vol#: 421

C 6892 Cheryl Herley Vol#: 421

C 6893 Brooke M. Griffin Vol#: 421

C 6894 D.J. Francis Vol#: 421

C 6895 Sue Spaven Vol#: 421

EMC 11288 Sharon Tamimi Vol#: 419

EMC 11289 Kimberly McGlaughlin Vol#: 419

EMC 11290 Cesar Pino Vol#: 419

EMC 11291 Sharon Kernan Vol#: 419

EMC 11292 Marty Greer Vol#: 419

EMC 11293 Linda Valentine Vol#: 419

EMC 11294 Linda Valentine Vol#: 419

EMC 11295 unsigned Vol#: 419

EMC 11296 Nathan Linscheid Vol#: 419

EMC 11297 Nathan Linscheid Vol#: 419

EMC 11298 Lorrie Forster Vol#: 419

EMC 11299 Lorrie Forster Vol#: 419

EMC 11300 Jena Henson Vol#: 419

EMC 11301 Jena Henson Vol#: 422

EMC 11302 Mike Carroll Vol#: 422

EMC 11303 Mike Carroll Vol#: 422

EMC 11304 Marcell Benoit Vol#: 422

EMC 11305 Marcell Benoit Vol#: 422

EMC 11306 Chris Striegel Vol#: 422

EMC 11307 Chris Striegel Vol#: 422

EMC 11308 Harold Tuchel Vol#: 422

EMC 11309 Mr. Irucka Embry Vol#: 422

EMC 11310 Catherine Gould Vol#: 422

EMC 11311 Catherine Gould Vol#: 422

EMC 11312 Linda Domian Vol#: 422

EMC 11313 Linda Domian Vol#: 422

EMC 11314 number not used Vol#: 422

EMC 11315 Len Hardy Vol#: 422

EMC 11316 Len Hardy Vol#: 422

EMC 11317 Robert Westhoff Vol#: 422

EMC 11318 Paul Lawrence Johnson Vol#: 422

EMC 11319 Kerry Karshna Vol#: 422

EMC 11320 Kerry Karshna Vol#: 422

EMC 11321 Elizabeth Riggs Vol#: 422

EMC 11322 Kelly Roby Vol#: 422

EMC 11323 Kelly Roby Vol#: 422

EMC 11324 Karen Anderson Vol#: 422

EMC 11325 Carlena Schroeder Vol#: 422

EMC 11326 Chidambaran Subramanian Vol#: 422

EMC 11327 Chidambaran Subramanian Vol#: 422

EMC 11328 Jenny Smith Vol#: 422

EMC 11329 Lacie Sosinski Vol#: 422

EMC 11330 Lacie Sosinski Vol#: 422

EMC 11331 Charles St. Clair Vol#: 422

EMC 11332 Charles St. Clair Vol#: 422

EMC 11333 Tammy St. Clair Vol#: 422

EMC 11334 Tammy St. Clair Vol#: 422

EMC 11335 James M. Nordlund Vol#: 422

EMC 11336 Beth Rasch Vol#: 422

EMC 11337 M. Landry Vol#: 422

EMC 11338 Sacker Pamela Vol#: 422

EMC 11339 Sacker Pamela Vol#: 422

EMC 11340 Richard and Dorothy Chamberlin Vol#: 422

EMC 11341 Stephanie Marble Vol#: 422

EMC 11342 Stephanie Marble Vol#: 422

EMC 11343 Randy Neumann Vol#: 422

EMC 11344 Randy Neumann Vol#: 422

EMC 11345 Carol Chapin Vol#: 422

EMC 11346 Virginia Ravenscroft-Scott Vol#: 422

EMC 11347 Carol Stemple Vol#: 422

EMC 11348 Rhonda Wilson Vol#: 422

EMC 11349 Jody Conrad Vol#: 422

EMC 11350 Stephen Bryant Vol#: 422

EMC 11351 Karl and Lynn Gulyash Vol#: 422

EMC 11352 Ms. Kelly Schneiderhan Vol#: 422

EMC 11353 Barbara Bloomberg Vol#: 422

EMC 11354 Cheri Anderson Vol#: 422

EMC 11355 Jonathan Mitchell Vol#: 422

EMC 11356 Laura Bergells Vol#: 422

EMC 11357 Karen Madias Vol#: 422

EMC 11358 unsigned Vol#: 422

EMC 11359 unsigned Vol#: 422

EMC 11360 Pam Erickson Vol#: 422

EMC 11361 Pam Erickson Vol#: 422

EMC 11362 Natasha and Noah Brenner Vol#: 422

EMC 11363 George Thompson Vol#: 422

EMC 11364 unsigned Vol#: 422

EMC 11365 Robin Rowe Vol#: 422

EMC 11366 Phil Schlotfeldt Vol#: 422

EMC 11367 Michelle Kelly Vol#: 422

EMC 11368 Stephanie Saravia Vol#: 422

EMC 11369 Alex Alexander Vol#: 422

EMC 11370 Christopher Cotrell Vol#: 422

EMC 11371 Sarah Hunt Vol#: 422

EMC 11372 Raleigh Klein Vol#: 422

EMC 11373 Philip H. Coe Vol#: 422

EMC 11374 Karen Klein Vol#: 422

EMC 11375 Irene Alexander Vol#: 422

EMC 11376 Carol Sulanke Vol#: 422

EMC 11377 John Ade' Vol#: 422

EMC 11378 Daniel Oliva Vol#: 422

EMC 11379 Judy Steele Vol#: 422

EMC 11380 Pat Schincariol Vol#: 422

EMC 11381 Dr. N. Paul Branden Vol#: 422

EMC 11382 Yumi Mizuno Vol#: 422

EMC 11383 Michael Jones Vol#: 422

EMC 11384 Meghan Gillan Vol#: 422

EMC 11385 Kellie Davis Vol#: 422

EMC 11386 Martha Hall Vol#: 422

EMC 11387 Lisa Slepetski Vol#: 422

EMC 11388 Cheryl Talbott Vol#: 422

EMC 11389 Chris Watson Vol#: 422

EMC 11390 Kathleen Ochs Vol#: 422

EMC 11391 Angela Foote Vol#: 422

EMC 11392 Martin Cibulka Vol#: 422

EMC 11393 Peggy Land Vol#: 422

EMC 11394 Ben Foley Vol#: 422

EMC 11395 Kelly Moyes Vol#: 422

EMC 11396 Chris Griffin Vol#: 422

EMC 11397 Robert Freeman, Sierra Club Vol#: 422

EMC 11398 Laura Smith Vol#: 422

EMC 11399 Christina Dedominicis Vol#: 422

EMC 11400 Barbara Werner Vol#: 422

00D-1662 Use of Xenotransplantation Products in Humans

C 11 GSK, Glaxo Smith Kline (United Kingdom) Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 7262 Daniel Steinhardt Vol#: 278

C 7263 Shannon Plyler Vol#: 278

C 7264 Richard Coenenberg Vol#: 278

C 7265 Amanda Selensky Vol#: 278

C 7266 Mrs. Connie Kinderdine Vol#: 278

C 7267 Carol Garzillo Vol#: 278

C 7268 Ivy Gullickson Vol#: 278

C 7269 Ginna Buchanan Vol#: 278

C 7270 National Organization for Women, Inc. Vol#: 278

C 7271 Gleni Katsika Vol#: 278

C 7272 Ruth Antonioni Vol#: 278

C 7273 Jill Philippi Vol#: 278

C 7274 Catherine Scheafer Vol#: 278

C 7275 Deborah Teixeira Vol#: 278

C 7276 Mark Perotti Vol#: 278

C 7277 Peter Birkeland Vol#: 278

C 7278 Lori Bellamy Vol#: 278

C 7279 Laura Randolph Vol#: 278

C 7280 James D. Mays Vol#: 278

C 7281 Kate Butterfield Vol#: 278

C 7282 Danielle Delancy Vol#: 278

C 7283 William Crowley Vol#: 278

C 7284 Robyn L. Priebe Vol#: 278

C 7285 Anton Jain Vol#: 278

C 7286 Katherine Jain Vol#: 278

C 7287 Sara Kandall Vol#: 278

C 7288 Hank Williams Vol#: 278

C 7289 Rev. Jennifer Willis Vol#: 278

C 7290 Rev. Daniel P. Villaume Vol#: 278

C 7291 Manette Teitelbaum Vol#: 278

C 7292 unreadable Vol#: 278

C 7293 Vanessa Goodman Vol#: 278

C 7294 Patricia R. Fitzpatrick Vol#: 278

C 7295 unreadable Vol#: 278

C 7296 Courty Davis Vol#: 278

C 7297 Kerri Roesner Vol#: 278

C 7298 Ms. Leslie Cummins Vol#: 278

C 7299 Sheila Parks Vol#: 278

C 7300 Jennifer Stewart Vol#: 278

C 7301 Chris Sherry & Lee Stewart Vol#: 278

C 7302 Hal Holbrook Vol#: 278

C 7303 Elizabeth Ross Vol#: 278

C 7304 Keith Harding Vol#: 278

C 7305 Stacy Raye Vol#: 278

C 7306 Connie Marken Vol#: 278

C 7307 Adrianna Reneau Vol#: 278

C 7308 Heather Robibauille Vol#: 278

C 7309 Dr. Paul Zloto Vol#: 278

C 7310 J. Flint Vol#: 278

C 7311 C. Droege Vol#: 278

C 7312 Sarah DiBenedeth Vol#: 278

C 7313 National Nurtional Foods Assn. Vol#: 278

C 7314 CSPI Vol#: 278

C 7315 unreadable Vol#: 278

C 7316 Elva Monkeal Vol#: 278

C 7317 GenEthic Alliance Vol#: 278

C 7318 Jerry Nuytten Vol#: 279

00P-1322 Food Labeling and Allergen Contamination Control

APE 114 WACSSG Vol#: 16

APE 115 Embassy Of Indonesia Vol#: 16

APE 116 Barbara A Solan Vol#: 16

C 267 Gunnel Jarl Vol#: 18

C 268 Patricia J Melton Vol#: 18

C 269 Julia Baresch Vol#: 18

C 270 Jannien Marquith Vol#: 18

C 271 Ginger Conner Vol#: 18

C 272 Anne F Russell Vol#: 18

C 273 Susan C Connick Vol#: 18

C 274 Patricia C Anderson Vol#: 18

C 275 Linda Kozak Vol#: 18

C 276 Susan Jacobson Vol#: 18

C 277 Graig Grube Vol#: 18

C 278 Kathleen Dawson Vol#: 18

C 279 Jean Close Vol#: 18

C 280 Agnes Wolf Vol#: 18

C 281 Opal Huettner Vol#: 18

C 282 Gloria D Parker Vol#: 18

C 283 Gail Tourville Vol#: 18

C 284 Carol Keith Vol#: 18

C 285 FORM LETTER COUNT 50 Vol#: 19

EAPE1 Parents of Food Allergic Kids Support Gr Vol#: 16

EAPE2 The Glutamate Association Vol#: 16

EAPE3 Pepperidge Farm, Inc. Vol#: 16

EAPE4 Gluten-Free Living Vol#: 16

EAPE5 M&M/Mars Vol#: 16

EAPE6 Adams, Div. of Pfizer Vol#: 16

EAPE7 CONAGRA FROZEN PREPARED FOODS Vol#: 16

EAPE8 Arent Fox Vol#: 16

EAPE9 Arent Fox Vol#: 16

EAPE10 Neogen Corporation Vol#: 16

EAPE11 FDA Vol#: 16

EAPE12 Council for Responsible Nutrition Vol#: 16

EAPE13 Coldwater Seafood Corporation Vol#: 16

EAPE14 The Glutamate Association Vol#: 16

EAPE15 Rexall Sundown, Inc. Vol#: 16

EAPE16 The Procter & Gamble Company Vol#: 16

EAPE17 International Food Information Council Vol#: 16

EAPE18 Novigen Sciences, Inc. Vol#: 16

EAPE19 self Vol#: 16

EAPE20 LI Food Allergy Support Group Vol#: 16

EAPE21 People for Mandatory Precautionary Label Vol#: 16

EAPE22 None Vol#: 16

EAPE23 Center For Celiac Research, University o Vol#: 16

EAPE24 The Food Allergy & Anaphylaxis Network Vol#: 16

EAPE25 PEPSI-COLA Vol#: 16

EAPE26 PEPSI-COLA Vol#: 16

EAPE27 AIB Vol#: 16

EAPE28 private citizen Vol#: 16

EAPE29 Celiac Sprue Association - Virginia Chap Vol#: 16

EAPE30 International Food Information Council Vol#: 16

EAPE31 WILD Flavors, Inc. Vol#: 16

EAPE32 ConAgra Grocery Products Vol#: 16

EAPE33 Center For Celiac Research Vol#: 16

EAPE34 McCORMICK & COMPANY, INC. Vol#: 16

EAPE35 SOS Foundation, Inc. Vol#: 16

EAPE36 WILD Flavors, Inc. Vol#: 16

EAPE37 Embassy of Grenada Vol#: 16

EAPE38 ConAgra Foods Vol#: 16

EAPE39 Distilled Spirits Council of the U.S. Vol#: 16

EAPE40 Food Allergy & Anaphylaxis Network Vol#: 16

EAPE41 The National Latex Allergy Network (ELAS Vol#: 16

EAPE42 Adams, a Division of Pfizer Vol#: 16

EAPE43 Golden Valley Microwave Foods Vol#: 16

EAPE44 Thompson Publishing Group Vol#: 16

EAPE45 Mintz Levin Cohn Ferris Glovsky & Popeo, Vol#: 16

EAPE46 International Food Information Council Vol#: 16

EAPE47 Quaker Oats Co. Vol#: 16

EAPE48 American Frozen Food Institute Vol#: 16

EAPE49 ENVIRON Corp Vol#: 17

EAPE50 Novigen Sciences Vol#: 17

EAPE51 Whole Foods Market Vol#: 17

EAPE52 American Peanut Council Vol#: 17

EAPE53 International Dairy Foods Association Vol#: 17

EAPE54 Ajinomoto U.S.A., Inc. Vol#: 17

EAPE55 National Restaurant Association Vol#: 17

EAPE56 American Academy of Allergy, Asthma, and Vol#: 17

EC 1 Mrs. Rhonda King Vol#: 17

EC 2 Miss test test Vol#: 17

EC 3 Ms. Barbara Erb Vol#: 17

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

EC 45 BUCHANAN CO. RURAL FAM ILY PRACTICE INC. Vol#: 3

EC 46 American Society for Action on Pain Vol#: 3

EC 47 Mr. Laurence Felker Vol#: 3

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

SUP 1 C.R.L.P., Ctr. for Reproductive Law & Po Vol#: 10

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 150 Lisa Turner Vol#: 9

C 151 Paul M. Lappon Vol#: 9

C 152 Steven Gaskey Vol#: 9

C 153 The Center for Food Safety Vol#: 9

01P-0343 Metal/Metal Semi-Constrained Hip Joint Prosthesis

CCP 1 OSMA Vol#: 1

01P-0346 Modify 8/14/01 deadline re: submission & approval of PMA

ACK 1 HFA-305 Vol#: 1