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Dockets Management

Dockets Entered On September 7, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
2003N-0528 Revision of the Requirements for Spore-Forming Microorganisms
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0071 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
2006P-0158 Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
2007D-0234 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
2007M-0161 Premarket Approval for AxSYM AUSAB by Abbott Laboratories, P060003
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
2007P-0282 Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
2007P-0297 Request to reconsider the failure to approve Provenge
1978N-0038 Sunscreen Drug Products
EC 2280 Mrs. Kimberly Economou Vol #: 161
EC 2281 Mrs. cindy petracelli Vol #: 161
EC 2282 Mrs. Martha Law Vol #: 161
EC 2283 Ms. Susan Jakubiak Vol #: 161
EC 2284 Dr. Carolyn Friedman Vol #: 161
EC 2285 Mrs. Lisa Hadlock Vol #: 161
EC 2286 Ms. Maya Ezzeddine Vol #: 161
EC 2287 Mr. Michael Welch Vol #: 161
EC 2288 Ms. Kelly Reed Vol #: 161
EC 2289 Ms. Deniz Tuncer Vol #: 161
EC 2290 Ms. Kata Orndorff Vol #: 161
EC 2291 Mrs. Theresa Fleming Vol #: 161
EC 2292 Mrs. elena emmons Vol #: 161
EC 2293 Mrs. Jessica Armbrust Vol #: 161
EC 2294 Ms. Scarletta Phoenix Vol #: 161
EC 2295 Mr. Dan Kittredge Vol #: 161
EC 2296 Ms. Tracy Balazy Vol #: 161
EC 2297 Mrs. astrid frey Vol #: 161
EC 2298 Mrs. Rosemarie Kuharick Vol #: 161
EC 2299 Mrs. Michelle C Dobey Vol #: 161
EC 2300 Ms. Lauren Webster Vol #: 161
EC 2301 Ms. Brenda Mackey Vol #: 161
EC 2302 Mrs. Holly Reilly Vol #: 161
EC 2303 Mrs. Joy Bukowski Vol #: 161
EC 2304 Ms. christy simons Vol #: 161
EC 2305 Ms. Jain Irvine Vol #: 161
EC 2306 Ms. Claire Knauth Vol #: 161
EC 2307 Mrs. Laura Bazan Vol #: 161
EC 2308 Ms. Chelsea Lee Vol #: 161
EC 2309 Mrs. Liza Alexander Vol #: 161
EC 2310 Ms. China Short Vol #: 161
EC 2311 Mrs. Annette Fambrough Vol #: 161
EC 2312 Mrs. Tracy O'Connell Vol #: 161
EC 2313 Dr. Holly Bottoms Vol #: 161
EC 2314 Ms. Bronwyn Scott Vol #: 161
EC 2315 Mrs. Gail Gagnon Vol #: 161
EC 2316 the new york hospital Vol #: 161
EC 2317 Mrs. Char VanderBent Vol #: 161
EC 2318 Ms. L Murphy Vol #: 161
EC 2319 Ms. Christie Bergeron Vol #: 161
EC 2320 Ms. Melissa Weiner Vol #: 161
EC 2321 Ms. Virginia Suchodolski Vol #: 161
EC 2322 Mr. Larry Mills Vol #: 161
EC 2323 Ms. Carolyn Eden Vol #: 161
EC 2324 Mrs. Denise Kelly Vol #: 161
EC 2325 Ms. Jenny Hayes Vol #: 161
EC 2326 Mrs. Yara Fernandez Vol #: 161
EC 2327 Ms. Sandra Halverson Vol #: 161
EC 2328 Mr. Greg Thompson Vol #: 161
EC 2329 Mrs. beatrice kerniss Vol #: 161
EC 2330 Mrs. amanda felix Vol #: 161
EC 2331 Equalibrium Bar Pty Ltd Vol #: 161
EC 2332 Ms. Elizabeth Pepper Vol #: 161
EC 2333 Miss. Andrea Hoekzema Vol #: 161
EC 2334 Ms. Kim Agalsoff Vol #: 161
EC 2335 The Cancer Crusaders Organization Vol #: 161
EC 2336 Mrs. Michelle Veasey Vol #: 161
EC 2337 Mrs. K. Gillan Vol #: 161
EC 2338 Ms. laura spera Vol #: 161
EC 2339 Ms. Susan Mucha Vol #: 161
EC 2340 Mrs. Doree Medrano Vol #: 161
EC 2341 Mr. Richard Lane Vol #: 161
EC 2342 Mr. Joseph Newland Vol #: 161
EC 2343 Mrs. Mar;y Anne Goetz Vol #: 161
EC 2344 Ms. lara taber Vol #: 161
EC 2345 Mrs. Kimberly Fisher Vol #: 161
EC 2346 Mrs. Jill Graham Vol #: 161
EC 2347 Mrs. Dawn Cejka Vol #: 161
EC 2348 Mrs. Irene Wagner Vol #: 161
EC 2349 Mrs. ellie grinspun Vol #: 161
EC 2350 Ms. Peri Caylor Vol #: 161
EC 2351 Ms. M Burge Vol #: 161
EC 2352 Mr. Bart Hackworth Vol #: 161
2003N-0528 Revision of the Requirements for Spore-Forming Microorganisms
GDL 2 Guidance for Industry Vol #: 1
NAD 2 FDA Vol #: 1
2005H-0271 Civil Money Penalty: TMJ Implants, Inc.
BRF 3 FDA/CDRH Vol #: 245
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 1996 S Hutching Vol #: 19
C 1997 C. Moore Vol #: 19
C 1998 D Jones Vol #: 19
C 1999 B Miner Vol #: 19
C 2000 F Winfield Sr Vol #: 19
C 2001 W Buchheit Vol #: 19
C 2002 M Brown Vol #: 19
C 2003 S Swanson Vol #: 19
C 2004 D Anderson Vol #: 19
C 2005 M Zabner Vol #: 19
C 2006 D Brenneman Vol #: 19
C 2007 E Tilley Vol #: 19
C 2008 T Fisch Vol #: 19
C 2009 H Fugere Vol #: 19
C 2010 M Galbraith Vol #: 19
C 2011 G Novak Vol #: 19
C 2012 R Townley Vol #: 19
C 2013 T McDonald Vol #: 19
C 2014 D Ritchie Vol #: 19
C 2015 D Hamilton Vol #: 19
C 2016 S McQuillin Vol #: 19
C 2017 M Sheckelford Vol #: 19
C 2018 N Lee Vol #: 19
C 2019 B Duffey Vol #: 19
C 2020 S Matulis Vol #: 19
C 2021 L Hammond Vol #: 19
C 2022 S Pemp Vol #: 19
C 2023 R Lumbrix Vol #: 19
C 2024 J Williams Vol #: 19
C 2025 L Roos Vol #: 19
C 2026 J Meck Vol #: 19
C 2027 J Parrinello Vol #: 19
C 2028 P. Harris Vol #: 19
C 2029 W Woolsey Vol #: 19
C 2030 D Vodden Vol #: 19
C 2031 P Dusek Vol #: 19
C 2032 M Hajicek Vol #: 19
C 2033 R McConnell Vol #: 19
C 2034 H Scott Vol #: 19
C 2035 C Lehozky Vol #: 19
C 2036 M Hawkes Vol #: 19
C 2037 L Daymon Vol #: 19
C 2038 F Conway Vol #: 19
C 2039 R Barton Vol #: 19
C 2040 S Stovall Vol #: 19
C 2041 J Abshire Vol #: 19
C 2042 F Etienne Vol #: 25
C 2043 M Bovier Vol #: 25
C 2044 I Jones Vol #: 25
C 2045 P Kendall Vol #: 25
C 2046 L. Larias Vol #: 25
C 2047 B Wilt Vol #: 25
C 2048 G Stone Vol #: 25
C 2049 K Covel Vol #: 25
C 2050 P Blaine Vol #: 25
C 2051 E Roof Vol #: 25
C 2052 A Floyd Vol #: 25
C 2053 F Rhodes Vol #: 25
C 2054 R Armstrong Vol #: 25
C 2055 J Kramer Vol #: 25
C 2056 A Butler Vol #: 25
C 2057 E Shelton Vol #: 25
C 2058 S Johnson Vol #: 25
C 2059 M Friedman Vol #: 25
C 2060 A Bliss Vol #: 25
C 2061 unlegible signature Vol #: 25
C 2062 P Fleming Vol #: 25
C 2063 M Mimnaugh Vol #: 25
C 2064 J Elliott Vol #: 25
C 2065 M Hale Vol #: 25
C 2066 A Carter Vol #: 25
C 2067 M Richard Vol #: 25
C 2068 B Jenkins Vol #: 25
2006P-0071 513 (e) Reclassification of Tissue Adhesive For Soft Tissue Approximation
C 3 Johnson & Johnson Vol #: 2
2006P-0158 Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
EMC 101 Sam Walker Vol #: 1
EMC 102 Melanie Tschirhart Vol #: 1
EMC 103 Clint Davis Vol #: 1
EMC 104 Joseph Pryber Vol #: 1
EMC 105 Mercedes Dzindzeleta Vol #: 1
EMC 106 Donna Hoaglin Vol #: 1
EMC 107 Kenneth Smith Vol #: 1
EMC 108 Nicholas Jouvanis Vol #: 1
EMC 109 Rene' Conrad Vol #: 1
EMC 110 Jerry Irwin Vol #: 1
EMC 111 George Zuk Vol #: 1
EMC 112 Jacqueline Fralley Vol #: 1
EMC 113 Debbie Graham Vol #: 1
EMC 114 Tiffany Hutton Vol #: 1
EMC 115 Michelle Deerfoot-Emuryan Vol #: 1
EMC 116 George DeCarlo Vol #: 1
EMC 117 Candace Reed Vol #: 1
EMC 118 Sherrie Wilson Vol #: 1
EMC 119 Sally McClure Vol #: 1
EMC 120 Liisa Wale Vol #: 1
EMC 121 Joyce H, Jenainati Vol #: 1
EMC 122 Mark Bosnian Vol #: 1
EMC 123 David Shelton Vol #: 1
EMC 124 Paula Behr Vol #: 1
EMC 125 Bobbie Flowers Vol #: 1
EMC 126 Marilyn Cameron Vol #: 1
EMC 127 Clifford Meyer Vol #: 1
EMC 128 Christine Tindall Vol #: 1
EMC 129 Michelle Reed Vol #: 1
EMC 130 J B Pearce, Sr Vol #: 1
EMC 131 Jana Shiloh Vol #: 1
EMC 132 Lynn Congo Vol #: 1
EMC 133 Gayle Eversole Vol #: 1
EMC 134 Wayne Robertson Vol #: 1
EMC 135 Linda Robbins Vol #: 1
EMC 136 Glenn McLaren Vol #: 1
EMC 137 Renee Horne Vol #: 1
EMC 138 Patricia McCampbell Vol #: 1
EMC 139 Ralph Nigro Vol #: 1
EMC 140 Linda Pullano Vol #: 1
EMC 141 Channing Quinn Carter Vol #: 1
EMC 142 Ruth Kelley Vol #: 1
EMC 143 Dena Turner Vol #: 1
EMC 144 Mary Emison Vol #: 1
EMC 145 Brigette Masone Vol #: 1
EMC 146 Martha Boufford Vol #: 1
EMC 147 Judith Lorraine Vol #: 1
EMC 148 Terry and Jana Carlson Vol #: 1
EMC 149 Mrs. Ella Callam Vol #: 1
EMC 150 Louis Blois Vol #: 1
EMC 151 Lucia Ploskey Vol #: 1
EMC 152 Sean Hinckley Vol #: 1
EMC 153 Taza Guthrie Vol #: 1
EMC 154 Kamie Stoner Vol #: 1
EMC 155 Erik Scanlan Vol #: 1
EMC 156 Beverly Jennings Vol #: 1
EMC 157 Ravi Grover Vol #: 1
EMC 158 Mary Halligan Vol #: 1
EMC 159 Diane Gruelle Vol #: 1
EMC 160 Janet-Lee Halish Vol #: 1
EMC 161 Karen Lavelle Vol #: 1
EMC 162 Robert Z. Cashman Vol #: 1
EMC 163 Patricia Perry Vol #: 1
EMC 164 Alicia Mattie Vol #: 1
EMC 165 Tanya Codispodi Vol #: 1
EMC 166 Evelyn Craig Vol #: 1
EMC 167 Richard Matheny Vol #: 1
EMC 168 Anne Skorupski Vol #: 1
EMC 169 Sonja Stone Vol #: 1
EMC 170 Kenda Varney Vol #: 1
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
EC 2328 Mrs. claudia pongratz Vol #: 18
EC 2329 Ms. Diana Bickford Vol #: 18
EC 2330 Mrs. Larinda Merkins Vol #: 18
EC 2331 Natural Solutions Foundation Vol #: 18
EC 2332 Mr. Eli Dumitru Vol #: 18
EC 2333 Ms. Diane Panella Vol #: 18
EC 2334 Mr. Tim Shullberg Vol #: 18
EC 2335 Mr. Steve Schenck Vol #: 18
EC 2336 Mr. Alvin Arlitz Vol #: 18
EC 2337 Ms. Julie Schwaiger Vol #: 18
EC 2338 Wild Iris Healthy Choices Vol #: 18
EC 2339 Natural Solutins Vol #: 18
EC 2340 Mrs. Elizabeth Butler Vol #: 18
EC 2341 Mrs. Karen Newman Vol #: 18
EC 2342 Dr. James Coronato Vol #: 18
EC 2343 Mr. Ronnie Harris Vol #: 18
EC 2344 Mr. Brannen Acor Vol #: 18
EC 2345 Mrs. Jane Coogen Vol #: 18
EC 2346 Mr. Ronnie Harris Vol #: 18
EC 2347 Mrs. Tammy Damalcheruvu Vol #: 18
EC 2348 Ms. Sharon Jonas Vol #: 18
EC 2349 Mr. JAMES ARNOLD Vol #: 18
EC 2350 Ms. patricia nussbaum Vol #: 18
EC 2351 Miss. Carrie Mackerwicz Vol #: 18
EC 2352 Mr. Roland Marconi Vol #: 18
EC 2353 Mr. Thomas Clements Vol #: 18
EC 2354 Mrs. Cortney Wesolowski Vol #: 18
EC 2355 American Medical Association Vol #: 18
2007D-0234 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
C 1 CLOSURE Vol #: 1
C 2 Stanford University School of Medicine Vol #: 1
2007M-0161 Premarket Approval for AxSYM AUSAB by Abbott Laboratories, P060003
ELET 1 FDA/CDRH Vol #: 1
2007N-0277 Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing
EC 6 Dr. Jonathan C Vol #: 1
EC 7 Mr. Christian Silva Vol #: 1
EC 8 Food Labeling Vol #: 1
EC 9 Mr. Kriston Cartwright Vol #: 1
EC 10 Mr. Daniel Duran Vol #: 1
EC 11 Glycemic Index Ltd Vol #: 1
EC 12 label the food Vol #: 1
EC 13 iam a true zoe Vol #: 1
EC 14 Mr. b d Vol #: 1
EC 15 g- unit Vol #: 1
EC 16 Choices International Foundation Vol #: 1
2007P-0282 Require all products labels to include this information: Products % Costs Packaging: 80% Content: 20%
EC 19 Ms. Terry Stone Vol #: 1
EC 20 Mr. Matthew Hall Vol #: 1
EC 21 Dr. Timothy Perkins Vol #: 1
EC 22 Mrs. Cynthia Dwyer Vol #: 1
EC 23 Mr. Michael Rainville Vol #: 1
EC 24 Ms. Elise Eaton Vol #: 1
EC 25 Mr. Bryan Lund Vol #: 1
EC 26 University of Vermont Vol #: 1
EC 27 Mr. Robert Kenney Vol #: 1
EC 28 Mr. Roland Dion Vol #: 1
2007P-0297 Request to reconsider the failure to approve Provenge
EC 21 Mr. Gerald Ruley Vol #: 1
EC 22 Mr. Ben Kraieski Vol #: 1
EC 23 Mr. Patrick Hape Vol #: 1
EC 24 Mr. chris sefton Vol #: 1
EC 25 Mr. Joe Nadolny Vol #: 1
EC 26 Mr. Richard Freese Vol #: 1
EC 27 Mr. Terry Rush Vol #: 1
EC 28 Mr. David Friedline Vol #: 1
EC 29 Mr. William McGrath PE Vol #: 1
EC 30 Mr. Paul Hollander Vol #: 1
EC 31 Mr. Ernest Swauger Vol #: 1
EC 32 Mr. Melvin Flores Vol #: 1
EC 33 Mr. Robert Range Vol #: 1
EC 34 Mr. Lawrence Shultz Vol #: 1
EC 35 Mr. Steve Frey Vol #: 1
EC 36 Self Vol #: 1
EC 37 Mr. Matthew Jurmann Vol #: 1
EC 38 US Army Vol #: 1
EC 39 Mr. Mike Bauman Vol #: 1
EC 40 Mrs. JUDY BENSON Vol #: 1
EC 41 Mr. Kevin Dalton Vol #: 1
EC 42 Mr. Dan Elliott Vol #: 1
EC 43 Miss. Dore Newell Vol #: 1
EC 44 Dr. Vincent Adams Vol #: 1
EC 45 Mr. Michael Hill Vol #: 1
EC 46 Mr. Michael Lambert Vol #: 1
EC 47 Mr. Ron Sampson Vol #: 1
EC 48 Ms. Sandra Poor Vol #: 1
EC 49 Ms. Jacquelyn Norman Vol #: 1
EC 50 Mr. robert cardinale Vol #: 1
EC 51 Care to Live Vol #: 1
EC 52 Ms. Lori Gluth Vol #: 1
EC 53 Mr. James Hadland Vol #: 1
EC 54 Mr. Michael Nordstrom Vol #: 1
EC 55 Mr. Douglas Grier Vol #: 1
EC 56 Mrs. Suzanne Warnke Vol #: 1
EC 57 Mr. JOHN TCHEN Vol #: 1
EC 58 Mr. arthur burgess Vol #: 1
EC 59 Mr. G. Markham Howell, Jr. Vol #: 1
EC 60 Mr. carlos costa Vol #: 1
EC 61 Mr. Larry Ryherd Vol #: 1
EC 62 Mrs. Viv Saunders Vol #: 1
EC 63 Mr. Colin Halliwell Vol #: 1
EC 64 Mr. Brad Wick Vol #: 1
EC 65 Mr. Patrick wear Vol #: 1
EC 66 Mr. jon hershey Vol #: 1
EC 67 University of Southern Medical School Vol #: 1
EC 68 Mr. Lee Klotz Vol #: 1
EC 69 Mrs. Shirley Blackburn Vol #: 1
EC 70 William G Stockglausner CPA PC Vol #: 1
EC 71 Mr. Jim Jones Vol #: 1
EC 72 Ms. Stephanie Thomas Vol #: 1
EC 73 Mr. Patrick Hape Vol #: 1
EC 74 Mr. John Greenwood Vol #: 1

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