Table of Contents

91N-0281 Effect date for PMA Silicone Inflatable Breast Prosthesis

BKG 1 BACKGROUND Vol#: 1

NFR 1 Vol#: 17

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5868 Patricia A D Andrea Vol#: 142

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE LINKED COMMENTS DUPLICATE THOSE FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 52 Joshua A. Barwick Vol#: 3

C 53 Helen Woodhull Vol#: 3

C 54 Voices for Animals Vol#: 3

C 55 Linda Lamb Vol#: 3

C 56 Chris Mandell Vol#: 3

C 57 Dr. Susan Zimmer Vol#: 3

C 58 Mr. Priscilla Carpender Vol#: 3

C 59 Dennis & Ulle-Mai M. Ruben Vol#: 3

C 60 Susan Kalev Vol#: 3

C 61 D. Corolla Vol#: 3

C 62 Elinore Gordon Vol#: 3

C 63 Barbara Corwin Vol#: 3

C 64 Dorothy C. Ramsaier Vol#: 3

C 65 Christine A. Dorchak Vol#: 3

C 66 Paula Shoots Vol#: 3

C 67 Marjorie DiMeo Vol#: 3

NCR 1 Vol#: 3

97P-0197 Require that warning labels about risks of salmonella enteri

C 53 Joshua A. Barwick Vol#: 2

C 54 Helen Woodhull Vol#: 2

C 55 Voices for Animals Vol#: 2

C 56 Linda Lamb Vol#: 2

C 57 Chris Mandell Vol#: 2

C 58 Dr. Susan Zimmer Vol#: 2

C 59 Mr. Priscilla Carpender Vol#: 2

C 60 Dennis & Ulle-Mai M. Ruben Vol#: 2

C 61 Susan Kalev Vol#: 2

C 62 D. Corolla Vol#: 2

C 63 Elinore Gordon Vol#: 2

C 64 Barbara Corwin Vol#: 2

C 65 Dorothy C. Ramsaier Vol#: 2

C 66 Christine A. Dorchak Vol#: 2

C 67 Paula Shoots Vol#: 2

C 68 Marjorie DiMeo Vol#: 2

NCR 1 Vol#: 2

98D-0362 Stability Testing of Drug Substances and Drug Products

NM 2 Vol#: 5

98H-1120 Civil Money Penalties; Will Halpine & Richard Caldwell,d/b/a

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

98N-0581 Requirements for Testing Human Blood Donors

BKG 1 BACKGROUND Vol#: 1

NPR 1 Vol#: 1

98N-0607 General Requirements for Blood,Blood Components and Derivati

NPR 1 Vol#: 1

98N-0617 Treatment of Narcotic Dependence

C 7 Kings View Vol#: 1

EC 2 Paul L (privacy) Vol#: 1

98N-0673 Revisions to Requirements to Blood,Blood Components & Plasma

BKG 1 BACKGROUND Vol#: 1

NFR 1 Vol#: 1

NPR 1 Vol#: 1

98N-0815 Plasma Derivatives & Other Blood-Derived Products

NAP 1 Vol#: 1

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

C 4689 Siobhan Hancock Vol#: 135

C 4690 Victor Owen Vol#: 135

C 4691 Helga Von Sydow & George Ancona Vol#: 135

C 4692 Helen Jo Williams Vol#: 135

C 4693 Stacy Stein Vol#: 135

C 4694 Gloria Foster Vol#: 135

C 4695 Patricia A. D'Andrea Vol#: 135

C 4696 Josefina Alvarez Vol#: 135

C 4697 The Waldorf School Vol#: 135

C 4698 Ruth M. Hartig Vol#: 135

C 4699 Eric S. Vol#: 135

C 4700 People for Pure Foods Vol#: 135

C 4701 Arleen Fraser Vol#: 135

C 4702 Robert Lee Bryan Vol#: 135

C 4703 Susan Trischman Vol#: 135

C 4704 Tomoyo Ishikura (Japan) Vol#: 135

C 4705 M. Goodson Vol#: 135

C 4706 Robin G. Bianchi Vol#: 135

C 4707 Iris Demas Vol#: 135

C 4708 Charles F. Hauser Vol#: 135

C 4709 Rath & Strong/Aon Consulting Vol#: 135

C 4710 Mrs. Lana Huston Vol#: 135

C 4711 Ian Kirk Vol#: 135

C 4712 Corrie Wardlaw Vol#: 135

C 4713 Merita Trohimovich Pollard Vol#: 135

C 4714 Leasa De Martini-Strong Vol#: 135

C 4715 Jennifer Claster Vol#: 135

C 4716 Lynn Markham Vol#: 135

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 52 Joshua A. Barwick Vol#: 6

C 53 Helen Woodhull Vol#: 6

C 54 Voices for Animals Vol#: 6

C 55 Linda Lamb Vol#: 6

C 56 Chris Mandell Vol#: 6

C 57 Dr. Susan Zimmer Vol#: 6

C 58 Mr. Priscilla Carpender Vol#: 6

C 59 Dennis & Ulle-Mai M. Ruben Vol#: 6

C 60 Susan Kalev Vol#: 6

C 61 D. Corolla Vol#: 6

C 62 Elinore Gordon Vol#: 6

C 63 Barbara Corwin Vol#: 6

C 64 Dorothy C. Ramsaier Vol#: 6

C 65 Christine A. Dorchak Vol#: 6

C 66 Paula Shoots Vol#: 6

C 67 Marjorie DiMeo Vol#: 6

NCR 1 Vol#: 6

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 219 Emma Vol#: 9

C 220 Melanie Fleegman Vol#: 9

C 221 Sinko Vol#: 9

C 222 Chad Foley Vol#: 9

C 223 Allen Flen Vol#: 9

C 224 N. Sacco Vol#: 9

C 225 No Signature Vol#: 9

C 226 No Signature Vol#: 9

C 227 Mallon A. Baroch Vol#: 9

C 228 Illegible Vol#: 9

C 229 Candace Lombiacitz Vol#: 9

C 230 Mico Kelly Vol#: 9

C 231 Maj Baird Vol#: 9

C 232 Illegible Vol#: 9

C 233 Kris Kiblans Vol#: 9

C 234 Fran Wolfe Vol#: 9

C 235 Illegible Vol#: 9

C 236 Casey Gordan Vol#: 9

C 237 Dennis Demers Vol#: 9

C 238 Denise Bolton Vol#: 9

C 239 Illegible Vol#: 9

C 240 Ruby Loraine Vol#: 9

C 241 Tracy Porte Vol#: 9

C 242 Rob Kogot Vol#: 9

C 243 Vicki Arsenault Vol#: 9

C 244 Glen Banult Vol#: 9

C 245 Kathleen O'Connell Vol#: 9

C 246 J. Woods Vol#: 9

C 247 Melanie Paul Vol#: 9

C 248 Sean Adauskas Vol#: 9

C 249 Diana Brosseau Vol#: 9

C 250 R. Stetten Vol#: 9

C 251 Illegible Vol#: 9

C 252 Anna Spencer Vol#: 9

C 253 Jason Perry Vol#: 9

C 254 Bonnie Livendale Vol#: 9

C 255 Lisa O'Neil Vol#: 9

C 256 Therese A. Piacerk Vol#: 9

C 257 Chris Herth Vol#: 9

C 258 B. K. Vol#: 9

C 259 Bianca Skerritt-Perta Vol#: 9

C 260 Illegible Vol#: 9

C 261 Valerie DePryster Vol#: 9

C 262 M. Levin Vol#: 9

C 263 No Signature Vol#: 9

C 264 Joe McIntire Vol#: 9

C 265 Stephanie Waij Vol#: 9

C 266 Candace Bluse Vol#: 9

C 267 Tiffany Dely Vol#: 9

C 268 Illegible Vol#: 9

C 269 Andra Fuller Vol#: 15

C 270 Christina Vol#: 15

C 271 Carolyn Bancroft Vol#: 15

C 272 No Signature Vol#: 15

C 273 Ken Cole Vol#: 15

C 274 Susan Barden Vol#: 15

C 275 Eve Ermer Vol#: 15

C 276 No Signature Vol#: 15

C 277 Mitch Vol#: 15

C 278 Diana Spaulding Vol#: 15

C 279 Ann G. Straub Vol#: 15

C 280 Illegible Vol#: 15

C 281 Carey J. Paul Vol#: 15

C 282 Illegible Vol#: 15

C 283 Illegible Vol#: 15

C 284 Patty Cooper Vol#: 15

C 285 Jennifer N. Nippon Vol#: 15

C 286 Matt Taffel Vol#: 15

C 287 Lori Gregoire Vol#: 15

C 288 Vivian Buckley Vol#: 15

C 289 Noelle Nole Vol#: 15

C 290 Roy Moran Vol#: 15

C 291 Adrian Snider Vol#: 15

C 292 Illegible Vol#: 15

C 293 No Signature Vol#: 15

C 294 Ellen Vol#: 15

C 295 Jennifer DeGeorge Vol#: 15

C 296 S. Reid Vol#: 15

C 297 Susan Phills Vol#: 15

C 298 Bill Johnson Vol#: 15

C 299 Usaac Lornelzo Vol#: 15

C 300 Illegible Vol#: 15

C 301 Stacey Dell Vol#: 15

C 302 Bernand Moore Vol#: 15

C 303 Jamie Vol#: 15

C 304 Sou Zach Vol#: 15

C 305 Thara Steve Vol#: 15

C 306 Tarri Vol#: 15

C 307 Harland Vol#: 15

C 308 Karen Satter Vol#: 15

C 309 Marcus Boksa Vol#: 15

C 310 Illegible Vol#: 15

C 311 Sara Smith Vol#: 15

C 312 M. B. Vol#: 15

C 313 Chelsea Anne Pemberton Vol#: 15

C 314 Illegible Vol#: 15

C 315 Cory A. Shook Vol#: 15

C 316 Dianne Maxwell Vol#: 15

C 317 Nate Shumway Vol#: 15

C 318 Sean Gray Vol#: 15

C 319 Lizah Carey Vol#: 15

C 320 Brooke Jones Vol#: 15

C 321 Meridith Vol#: 15

C 322 Aaron Pascal Vol#: 15

C 323 Jerry Criton Vol#: 15

C 324 Kattie Rotax Vol#: 15

C 325 Julie DiFari Vol#: 15

C 326 Jon Kilian Vol#: 15

C 327 Mike Wahl Vol#: 15

C 328 Lara E. Hoyt Vol#: 15

C 329 Victoria Shestock Vol#: 15

C 330 Chris Vol#: 15

C 331 No Signature Vol#: 15

C 332 Anne Conaway Peters Vol#: 15

C 333 Mary Ellis Bunn Vol#: 15

C 334 Freeman White Vol#: 15

C 335 Illegible Vol#: 15

C 336 Mare Jacobson Vol#: 15

C 337 Susan Contemarsh Vol#: 15

C 338 Jillane Supls Vol#: 15

C 339 Kidder Cami Vol#: 15

C 340 David Young Vol#: 15

C 341 No Signature Vol#: 15

C 342 Sharon M. Gwashe Vol#: 15

C 343 Alice Cardoza Vol#: 15

C 344 No Signature Vol#: 15

C 345 Nancy Stone Vol#: 15

C 346 P. Pierre Vol#: 15

C 347 Cheryl Stauffer Vol#: 15

C 348 Goldie Golding Vol#: 15

C 349 W. Barber Vol#: 15

C 350 Allison Vol#: 15

C 351 No Signature Vol#: 15

C 352 Nick Ide Vol#: 15

C 353 Windy Moore Vol#: 15

C 354 Stacey Orr Vol#: 15

C 355 Mortelina Florentina Vol#: 15

C 356 Sean Baggs Vol#: 15

C 357 Patricia Boksa Vol#: 15

C 358 David Spaulding Vol#: 15

C 359 Vanessa Bach Vol#: 15

C 360 Ann Sullivan Vol#: 15

C 361 Sherri Fuqua Vol#: 15

C 362 Cheryl Stauffer Vol#: 15

C 363 J. Stanford Vol#: 15

C 364 Alana Considine Vol#: 15

C 365 Stephanie Suddeth Vol#: 15

C 366 Stephanie Kilian Vol#: 15

C 367 Monica Vol#: 15

C 368 Jili Lyn Vol#: 15

C 369 Shaun Stephens Vol#: 16

C 370 Illegible Vol#: 16

C 371 Peter Cheryl Vol#: 16

C 372 Carmen Vol#: 16

C 373 No Signature Vol#: 16

C 374 No Signature Vol#: 16

C 375 No Signature Vol#: 16

C 376 No Signature Vol#: 16

C 377 Kelvin P. Wern Vol#: 16

C 378 Danielle Briton Vol#: 16

C 379 Ruth O'Meara Costello Vol#: 16

C 380 Melissa Biczak Vol#: 16

C 381 C. Waldman Vol#: 16

C 382 Illegible Vol#: 16

C 383 Ginny Massucco Vol#: 16

C 384 Jennifer Vol#: 16

C 385 Jessica Colom Vol#: 16

C 386 Winsor Love Vol#: 16

C 387 Kristin Betz Vol#: 16

C 388 Don Jenkins Vol#: 16

C 389 Betz Naeselz Vol#: 16

C 390 Illegible Vol#: 16

C 391 No Signature Vol#: 16

C 392 Illegible Vol#: 16

C 393 No Signature Vol#: 16

C 394 Cindy Pinto Vol#: 16

C 395 Jesse Ovelette Vol#: 16

C 396 Swan Lornitzo Vol#: 16

C 397 Dave Ayotte Vol#: 16

C 398 Ian Sawyer Vol#: 16

C 399 Stan Woliker Vol#: 16

C 400 Andrea Vol#: 16

C 401 Lori Morse Vol#: 16

C 402 Carl Ferrara Vol#: 16

C 403 Stephanie Pound Vol#: 16

C 404 C. R. Rousseau Vol#: 16

C 405 Jennie Finn Vol#: 16

C 406 Claire Thesing Vol#: 16

C 407 Annette Hotesz Vol#: 16

C 408 Margaret Davis Vol#: 16

C 409 No Signature Vol#: 16

C 410 G. Farmar Vol#: 16

C 411 Melissa Songer Vol#: 16

C 412 Scott Marion Vol#: 16

C 413 Rick Dorr Vol#: 16

C 414 No Signature Vol#: 16

C 415 Risa Braw Vol#: 16

C 416 No Signature Vol#: 16

C 417 No Signature Vol#: 16

C 418 Tina Lyon Vol#: 16

C 419 Rick Coutur Vol#: 16

C 420 Sage Evans Vol#: 16

C 421 Alex Moore Vol#: 16

C 422 Adrian Chen Vol#: 16

C 423 Illegible Vol#: 16

C 424 Michelle Anderson Vol#: 16

C 425 Jach Bush Vol#: 16

C 426 Kalita Bush Vol#: 16

C 427 No Signature Vol#: 16

C 428 Illegible Vol#: 16

C 429 May Sligh Vol#: 16

C 430 Andrew Steinberg Vol#: 16

C 431 Tamara Howe Vol#: 16

C 432 Lee Awbrey Vol#: 16

C 433 Lindsay Lathrop Vol#: 16

C 434 Lori Sherwin Vol#: 16

C 435 Illegible Vol#: 16

C 436 Illegible Vol#: 16

C 437 Patrick Burke Vol#: 16

C 438 Annie W. Buch Vol#: 16

C 439 Cecil Forgy Vol#: 16

C 440 Jessie Levanson Vol#: 16

C 441 M. B. Vol#: 16

C 442 Sarah Kim Vol#: 16

C 443 Teri M. Pechar Vol#: 16

C 444 Jonathan Gaithland Vol#: 16

C 445 Uri Feiner Vol#: 16

C 446 Sarah Kruger Vol#: 16

C 447 Erin C. Bell Vol#: 16

C 448 Danielle Fuller Vol#: 16

C 449 Christopher R. Carter Vol#: 16

C 450 Kathryn Hackett Vol#: 16

C 451 No Signature Vol#: 16

C 452 Dennis Vol#: 16

C 453 Rick Kobik Shaftsbury Vol#: 16

C 454 No Signature Vol#: 16

C 455 Kathleen P. Jensen Vol#: 16

C 456 No Signature Vol#: 16

C 457 Ryan S. Witbeck Vol#: 16

C 458 Jerome Long Vol#: 16

C 459 Emily Dy Vol#: 16

C 460 Emily R. Sheets Vol#: 16

C 461 S. DeSorrento Vol#: 16

C 462 No Signature Vol#: 16

C 463 Broob Bisson Vol#: 16

C 464 Kathy Foley-Giorgio Vol#: 16

C 465 No Signature Vol#: 16

C 466 Joan Palmer Vol#: 16

C 467 Jeanna Jensen Vol#: 16

C 468 Bev Irenberg Vol#: 16

C 469 No Signature Vol#: 16

99D-0296 Formal Meetings with Sponsors/Applicant for PDUFA Products

N 1 Vol#: 1

99H-0406 Civil Money Penalties;Mike Mola,Joe Mola,Gino Mola,d/b/a Mol

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1806 Civil Money Penalty;Kroger Corporation,dba King Soopers

LET 2 Dillon Companies dba King Soopers Vol#: 1

99H-1961 Civil Money Penalty;Kenneth Estes,dba Estes General Store

LET 2 Estes General Store Vol#: 1

99H-2494 Civil Money Penalty;IMS Group Inc,dba Quik Mart

ANS 1 IMS Gropu Inc d/b/a Quik Mart Vol#: 1

99H-2573 Civil Money Penalty;Ports Petroleum Company Inc,dba Fuel Mar

ANS 1 Ports Petroleum Co Inc Vol#: 1

99H-2697 Civil Money Penalty;Oeu Ghov,dba Al's Donuts

ANS 1 Al's Donuts Vol#: 1

99H-2701 Civil Money Penalty;7-Eleven Inc dba 7-Eleven Food Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99N-1393 State Petitions for Exemption from Preemption

N 2 Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EC 80 Lynn Markham Vol#: 24

99P-2630 Establish a Daily Value for "added sugars"

C 1 Barbara Abrams DrPH RD & 30 MD signaturs Vol#: 1