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Dockets Management
Dockets Entered On December 9, 2005
Table of Contents
Docket # Title
1976N-0052G OTC general comments & combinations
1998D-0266 Section 121 Positron Emission Tomography (PET) FDAMA
2000P-1491 Amend Definition & Standard of Identy for Parmesan Cheese
2001D-0044 Clinical Laboratory Improvement Amendments of 1988
2001D-0281 Proposed Globally Harmonized Alternative for PMA Procedures
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
2004N-0439 Current Good Manufacturing Practice for Positron Emission Tomography Drugs
2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
2005D-0312 Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
2005D-0356 Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
2005N-0329 Designation of New Animal Drugs for Minor Uses or Minor Species
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
2005N-0389 Agency Information Collection Activities; Proposed Collection; Comment Request; Reprocessed Single-Use Device Labeling
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
2005N-0426 Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
2005P-0293 Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies
2005P-0323 Immediately remove Adderall and Adderall XR from the market for safety reasons
2005P-0402 Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic-depressive illness."
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
1976N-0052G OTC general comments & combinations
ACK 2 HFA-305 to Foley & Lardner LLP Vol #: 35
PSA 1 American Council on Regulatory Compliance Vol #: 35
1998D-0266 Section 121 Positron Emission Tomography (PET) FDAMA
EC 2 P.E.T.Net Pharmaceuticals, Inc. Vol #: 15
EC 3 Cardinal Health Vol #: 15
2000P-1491 Amend Definition & Standard of Identy for Parmesan Cheese
EC 2 Mr. Robin Hills Vol #: 1
EC 3 Mr. Alan Moore Vol #: 1
2001D-0044 Clinical Laboratory Improvement Amendments of 1988
EC 17 American Soc for Clinical Laboratory Science Vol #: 5
EC 18 DSTDP, Centers for Disease Control and Prevention Vol #: 5
EC 19 NASTAD Vol #: 5
EC 20 Abaxis Vol #: 5
2001D-0281 Proposed Globally Harmonized Alternative for PMA Procedures
EC 2 Dolle Communications Vol #: 1
2002N-0273 Animal Proteins Prohibited in Ruminant Feed
EC 39 mother of three Vol #: 32
EC 40 Murray State University Breathitt Veterinary Cntr. Vol #: 32
EC 41 Titpon County Vol #: 32
EC 42 Mr. Thomas Johnson Vol #: 32
EC 43 F.B. Purnell Sausage Company Vol #: 32
EC 44 University of Tennessee Extension Vol #: 32
EC 45 Mr. Francis Schilling Vol #: 32
EC 46 Miss. Pamela Hardimon Vol #: 32
EC 47 Ms. Elizabeth Ungar Vol #: 32
EC 48 Mr. Brad King Vol #: 32
EC 49 Miss. Rebecca Stanger Vol #: 32
EC 50 So Oregon Animal Rights Society Vol #: 32
EC 51 Mrs. darcy flynn Vol #: 32
EC 52 Ms. Sharon Buazard Vol #: 32
EC 53 Ms. Jacqueline Gambairni Vol #: 32
EC 54 Mrs. Betsy Lambert Vol #: 32
EC 55 Mrs. Teri TOSDALE Vol #: 32
EC 56 Dr. Leah Winders Vol #: 32
EC 57 Mrs. Ronnie Steinau Vol #: 32
EC 58 Mrs. Jane Campbell Vol #: 32
EC 59 Ms. Jacqueline Stroud Vol #: 32
EC 60 Ms. Mary Domhan Vol #: 32
EC 61 Mrs. Helena McDonnell Vol #: 32
EC 62 Ms. Kate McDonald Vol #: 32
EC 63 Ms. Liberty Mulkani Vol #: 32
EC 64 Miss. Poornima Dasgupta Vol #: 32
EC 65 Mr. Chris Coen Vol #: 32
EC 66 Miss. Jane Leshinsky Vol #: 32
EC 67 Ms. Jen Girgen, J.D. Vol #: 32
EC 68 Mr. April Brumson Vol #: 32
EC 69 Mrs. Elizabeth Ferrari Vol #: 32
EC 70 Mr. Gary Burke Vol #: 32
EC 71 Ms. theresa domhan-adams Vol #: 32
EC 72 Ms. LiLi Rasekhi Vol #: 32
EC 73 Mrs. Natalie Morales Vol #: 32
EC 74 Mr. Dennis Robidoux Vol #: 32
EC 75 Dr. Allen Yun Vol #: 32
EC 76 Mrs. Barbara Potter Vol #: 32
EC 77 Ms. rebecca rader Vol #: 32
EC 78 individual consumer Vol #: 32
EC 79 Mr. marc strimpell Vol #: 32
EC 80 Ms. Janet Nicosia Vol #: 32
EC 81 Mr. David Godin Vol #: 32
EC 82 Ms. Karen Campo Vol #: 32
EC 83 Ms. Alana Willroth Vol #: 32
EC 84 Mrs. Susan Suter Vol #: 32
EC 85 Ms. Gail Camhi Vol #: 32
EC 86 Ms. Marnell Kelly Vol #: 32
EC 87 Mr. Steven Thalheimer Vol #: 32
EC 88 Mrs. Susan Clay Vol #: 32
EC 89 Mrs. Rita Beilke Vol #: 32
EC 90 Mr. Michael Barnes Vol #: 32
EC 91 Mrs. Heather Leughmyer Vol #: 32
EC 92 Ms. SHARON LATTA Vol #: 32
EC 93 Ms. Lana Luhm Vol #: 32
EC 94 Mrs. Clare Domhan Vol #: 32
EC 95 Mrs. Harriette Frank Vol #: 32
EC 96 Mr. Bobbie Flowers Vol #: 32
EC 97 Mrs. Djonna Elliott Vol #: 32
EC 98 Ms. Carly Myers Vol #: 32
EC 99 Mr. Mark Burwinkel Vol #: 32
EC 100 Mr. Scott Van Til Vol #: 32
EC 101 Miss. Astra Kalodukas Vol #: 32
EC 102 Ms. Karen Kirchdoerfer Vol #: 32
EC 103 Ms. Laurel Gress Vol #: 32
EC 104 Ms. Darcia Matulewicz Vol #: 32
EC 105 Mr. Rob Gonzalez Vol #: 32
EC 106 Miss. Becky Redgrift Vol #: 32
EC 107 farm sanctuary Vol #: 32
EC 108 Ms. Jane Spinney Vol #: 32
EC 109 Mrs. Barbara Kwasnik Vol #: 32
EC 110 Mrs. Barbara Kwasnik Vol #: 32
EC 111 Mrs. Debra Fischer Vol #: 32
EC 112 Mr. Robert Costello Vol #: 32
EC 113 Ms. Julie Troyer Vol #: 32
EC 114 Mrs. Shanna Starke Vol #: 32
EC 115 Ms. Christa Meyers Vol #: 32
EC 116 Mr. Kevin Crupi Vol #: 32
EC 117 Mrs. Dorothy Savage Vol #: 32
EC 118 Miss. Steffanie Schrader Vol #: 32
EC 119 Mrs. Nancy Peterson Vol #: 32
EC 120 Ms. Margarita McAuliffe Vol #: 32
EC 121 Ms. Diane Burgin Vol #: 32
EC 122 Miss. Suzanne McMillan Vol #: 32
EC 123 Dr. Patrick Cosgrove Vol #: 32
EC 124 Miss. munchi lok Vol #: 32
EC 125 Ms. Marliese Bonk Vol #: 32
EC 126 Individual Vol #: 32
EC 127 Ms. Kathleen Perry Vol #: 32
EC 128 Ms. Deborah Criswell Vol #: 32
EC 129 Ms. T Brockway Joyce Vol #: 32
EC 130 Ms. Heather Tyson Vol #: 32
EC 131 Ms. Laurie-Marie Pisciotta Vol #: 32
EC 132 Ms. Samantha Lane Vol #: 32
EC 133 Mrs. tammy wagner Vol #: 32
EC 134 Marshall County Commission Vol #: 32
EC 135 Consumer Vol #: 32
EC 136 Ms. Brita Sauer Vol #: 32
EC 137 Ms. Donna Cray Vol #: 32
EC 138 Ms. Vicki medlyn Vol #: 32
EC 139 Ms. Shannon Elliott Vol #: 32
EC 140 Mrs. Sandy Lynn Vol #: 32
EC 141 Franklin County Government, Tennessee Vol #: 32
EC 142 Ms. Jean Bevsek Vol #: 32
EC 143 Ms. Jean Bevsek Vol #: 32
EC 144 Mr. Jeffrey Wiles Vol #: 32
EC 145 Mrs. Lesley Parker-Rollins Vol #: 32
EC 146 Mrs. Rebecca Audet Vol #: 32
EC 147 Mrs. Nicole Morrow Vol #: 32
EC 148 none Vol #: 32
EC 149 Mrs. Liz Tanner Vol #: 32
EC 150 Mr. Andrew Testo Vol #: 32
EC 151 Miss. Lauren Winship Vol #: 32
EC 152 Miss. Jennifer Grout Vol #: 32
EC 153 Mrs. Sharon Reynolds Vol #: 32
EC 154 Ms. Jerri Miller Vol #: 32
EC 155 Ms. G. Rosa Vol #: 32
EC 156 Mrs. Georgia Herman Vol #: 32
EC 157 Ms. Antoinette Sellitto Vol #: 32
EC 158 Mr. John Kunick Vol #: 32
EC 159 none Vol #: 32
EC 160 Ms. Charity Meakes Vol #: 32
EC 161 Ms. Heather Buchman Vol #: 32
EC 162 Ms. Pamela Bickett Vol #: 32
EC 163 Member, Farm Sanctuary Vol #: 32
2003P-0132 Part 135 FDA regulations standard of identity frozen dessert
EC 2 Mr. Douglas Leman Vol #: 1
EC 3 Mrs. Nancy Hosford Vol #: 1
EC 4 southwest dairy museum Vol #: 2
EC 5 Mrs. Joy Britton Vol #: 1
EC 6 Mrs. Stephanie Simon Vol #: 2
EC 7 Mr. Nathan Martin Vol #: 1
EC 8 Mr. Alan Moore Vol #: 1
EC 9 Ms. D. L. Warnick Vol #: 1
2004N-0439 Current Good Manufacturing Practice for Positron Emission Tomography Drugs
EC 1 P.E.T.Net Pharmaceuticals, Inc. Vol #: 1
2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
EC 9 Ms. Meredith Warden Vol #: 1
EC 10 University of Illinois at Chicago Vol #: 1
EC 11 Dr. Rachel Long Vol #: 1
EC 12 Ms. Shayna Norman Vol #: 1
EC 13 Miss. Eugerie Douge Vol #: 1
EC 14 UIC College of Pharmacy Vol #: 1
EC 15 Miss. Claire Bolander Vol #: 1
EC 16 n/a Vol #: 1
EC 17 UIC College of Pharmacy Vol #: 1
EC 18 Ms. meg mclain Vol #: 1
EC 19 Watson Chapel School District Vol #: 1
2005D-0312 Guidance for Industry on ANDAs: Impurities in Drug Products; Chemistry, Manufacturing, and Controls Information; Availability
EC 2 Amgen Vol #: 1
EC 3
Attachment 		Pfizer Inc. Vol #: 1
2005D-0356 Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records
EC 1 ConAgra Foods, Inc. Vol #: 1
2005N-0329 Designation of New Animal Drugs for Minor Uses or Minor Species
EXT 1 Animal Health Institute Vol #: 1
2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
EC 278 Mr. Tari Steward Vol #: 5
EC 279 Mr. tony sherriff Vol #: 5
EC 280 Narconon Vol #: 5
EC 281 Miss. Rachel Montoya Vol #: 5
EC 282 Mrs. Brenda Svinos Vol #: 5
EC 283 Mrs. Pearl Lantz Vol #: 5
EC 284 Ms. Margaret Bell Vol #: 5
EC 285 Dr. R Bunch Vol #: 5
EC 286 Mr. David Lantz Vol #: 5
EC 287 Mrs. Charmel Sekulo Vol #: 5
EC 288 Mr. Dan Pittsenbarger Vol #: 5
EC 289 International Association of Scientologists Vol #: 5
EC 290 Mrs. Melody Brink Vol #: 5
EC 291 Mr. Todd Wilson Vol #: 5
EC 292 individual Vol #: 5
EC 293 Mr. John Hawkins Vol #: 5
EC 294 Mrs. Leanne Wilson Vol #: 5
EC 295 Mr. Kevin Hall Vol #: 5
EC 296 Ms. Komra Moriko Vol #: 5
EC 297 Mr. Fred Hall Vol #: 5
EC 298 Ms. Karen Fisher Vol #: 5
EC 299 Mr. James Doering Vol #: 5
EC 300 Mr. Evan Donahue Vol #: 5
EC 301 Mrs. Jan Johnson Vol #: 5
EC 302 Mr. Michael Draheim Vol #: 5
EC 303 Ms. Nanette Ciano Vol #: 5
EC 304 Mr. Gerald Staroba Vol #: 5
EC 305 Mrs. Barbara Ayash Vol #: 5
EC 306 private citizen Vol #: 5
EC 307 Berklee College Of Music Vol #: 5
EC 308 Mr. Craig Mackay Vol #: 5
EC 309 Mr. W. Gene Hunt Vol #: 5
EC 310 Mr. David Stobbe Vol #: 5
EC 311 Mr. Carter Manierre Vol #: 5
EC 312 Mr. Andre Afonso Vol #: 5
EC 313 Mr. Rand Davis Vol #: 5
EC 314 Mrs. Fran Mackay Vol #: 5
EC 315 Mrs. Nicole Fiorillo Vol #: 5
EC 316 Ms. Barbara Wright Vol #: 5
EC 317 Ms. Sue Harrison Vol #: 5
EC 318 Mrs. Christina Hammontree Vol #: 5
EC 319 Mr. George Harrison Vol #: 5
EC 320 Mrs. Caralyn Percy Vol #: 5
EC 321 Mr. David Mowles Vol #: 5
EC 322 Mr. Trevor Davis Vol #: 5
EC 323 Mrs. Christine Diana Vol #: 5
EC 324 Ms. Trudy Harris Vol #: 5
EC 325 Mr. Ken Daniells Vol #: 5
EC 326 Mr. Michael Harrison Vol #: 5
EC 327 Mr. James Plumb Vol #: 5
EC 328 Dr. Joseph Matievich Vol #: 5
EC 329 Mrs. Arlene Tessitore Vol #: 5
EC 330 Mr. Tom Hughes Vol #: 5
EC 331 Mrs. Arlene Tessitore Vol #: 5
EC 332 Mr. Fred Perkins Vol #: 5
EC 333 Ms. Thomas Norton Vol #: 5
EC 334 Miss. Abbi Baldarelli Vol #: 5
EC 335 Mrs. Trista Marquez Vol #: 5
EC 336 Mr. Nigel Unarie Vol #: 5
EC 337 Miss. Rebecca Crocker Vol #: 5
EC 338 Baxter Research Vol #: 5
EC 339 Mr. Paul Bourgeois Vol #: 5
EC 340 Ms. susan davis Vol #: 5
EC 341 Ms. Gloriamarie Araneda Vol #: 5
EC 342 Mrs. JoJo Zawawi Vol #: 5
EC 343 Ms. Sandra Ford Vol #: 5
EC 344 Mr. Erik Dabrowsky Vol #: 5
EC 345 Mrs. Patty Pritchett Vol #: 5
EC 346 Ms. Judith Adams Vol #: 5
EC 347 Ms. Nancy West Vol #: 5
EC 348 Dr. Joseph Valese Vol #: 5
EC 349 Ms. Linda Smith Vol #: 5
EC 350 Mr. David Vannier Vol #: 5
EC 351 Dr. Yuriy Kirichok Vol #: 5
EC 352 Ms. R. Moore Vol #: 5
EC 353 Mr. Robert Gilliam Vol #: 5
EC 354 Miss. Diane Ash Vol #: 5
EC 355 Mr. Ben Atwood Vol #: 5
EC 356 Mrs. Jennifer Tarling Vol #: 5
EC 357 Mr. Patrick Spruill Vol #: 5
EC 358 Ms. Caroline Nye Vol #: 5
EC 359
Attachment 		Mr. Houston Farrow Vol #: 5
EC 360 Mrs. Mercedes Alvarez Vol #: 5
EC 361 Mr. Ernest Ryan Vol #: 5
EC 362 Mr. Maurice Blehert Vol #: 5
EC 363 Mr. Leif Borgman Vol #: 5
EC 364 Mr. Russell McKevitt Vol #: 5
EC 365 Mr. john dale Vol #: 5
EC 366 CCHR Vol #: 5
EC 367 Mr. Peter Vilinsky Vol #: 5
2005N-0389 Agency Information Collection Activities; Proposed Collection; Comment Request; Reprocessed Single-Use Device Labeling
EC 1 MediSISS Vol #: 1
2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
EC 8 Mrs. Kathleen Cahill Vol #: 1
EC 9 Fluoroquinolone Toxicity Research Foundation Vol #: 1
EC 10 Mr. Bernhard Raez Vol #: 1
2005N-0426 Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
EC 1 Dolle Communications Vol #: 1
2005P-0293 Citizen Petition Regarding the Labeling of Vitamin A by Supplement Companies
LET 1 HFS-800 to David Getoff, CCN, FAAIM Vol #: 1
2005P-0323 Immediately remove Adderall and Adderall XR from the market for safety reasons
EC 3 Mr. Dave Lowe Vol #: 1
2005P-0402 Amend or permit amendment of the labeling of all lithium-containing drugs to include the additional indication "to reduce the incidence of suicide and suicide attempts in manic- depressive illness."
EC 1 Mr. Dave Lowe Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
EC 2 National Partnership for Women Vol #: 1
EC 3 Association of Reproductive Health Professionals Vol #: 1
EC 4 National Partnership for Women Vol #: 1

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