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Dockets Management

Dockets Entered On December 28, 2006
Table of Contents
Docket # Title
1977N-0094L Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
1978N-0065 Skin Bleaching Drug Products
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
2002P-0122 Request Rulemaking on Functional Foods & Establish Adv. Com.
2003N-0573 Draft Animal Cloning Risk Assessment
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
2004P-0349 Action on Products containing added Mercury
2006D-0303 Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
2006N-0292 Unique Device Identification
2006N-0465 Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting
2006P-0390 Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2006P-0415 Petition Seeking Regulation of Cloned Animals
2006P-0508 Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
2006P-0522 Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
2006P-0535 Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
1977N-0094L Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling
BKG 1 Background material Vol #: 1
1978N-0065 Skin Bleaching Drug Products
C 69 R. Yu, PhD, OMD Vol #: 15
C 70 Dermedica Innovative Dermatology Vol #: 15
C 71 L. Hobbs, MD Vol #: 15
C 72 State University of New York Downstate Medical Center Vol #: 15
C 73 Cosmetic & Laser Surgery Institute Vol #: 15
EC 542 Dr. Robin Septon Vol #: 19
EC 543 Hudson Dermatology Vol #: 19
EC 544 Dr. Vaughn Millner Vol #: 19
EC 545 American Academy of Dermatology Association Vol #: 19
EC 546 Mrs. Gail Churinetz Vol #: 19
EC 547 Mrs. Tracey Rowley Vol #: 19
EC 548 Mrs. rosalena garrett Vol #: 19
EC 549 Mrs. denise apicella Vol #: 19
EC 550 Dr. Pearl Grimes Vol #: 19
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
MM 4 FDA and Natural Products Association Vol #: 43
2002P-0122 Request Rulemaking on Functional Foods & Establish Adv. Com.
EC 4 Association of Food and Drug Officials (AFDO) Vol #: 2
EC 5 Natural Products Association Vol #: 2
2003N-0573 Draft Animal Cloning Risk Assessment
BKG 1 Risk Management Plan Vol #: 1
GDL 1 Draft Guidance Vol #: 1
NAD 1 FDA Vol #: 1
RA 1 Risk Assessment Vol #: 2
2003P-0544 Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
C 71 I. Imbasciani Vol #: 5
2004P-0349 Action on Products containing added Mercury
ANS 1 FDA/OC to CoMed, Coalition for Mercury-Free Drugs Vol #: 4
REF 1 Reference Material (1-75) Vol #: 6
2006D-0303 Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements
EC 5 Mrs. Deb Hofstetter Vol #: 1
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
EC 4825 Miss. Janet Parkinson Vol #: 26
EC 4826 Miss. Diane Knowles Vol #: 26
EC 4827 Mrs. Laura Briggs Vol #: 26
EC 4828 Mrs. Merry Ford Vol #: 26
EC 4829 Mr. Gregor Dick Vol #: 26
EC 4830 Mrs. Tonia Helm Vol #: 26
EC 4831 Mrs. Charlotte Sponseller Vol #: 26
EC 4832 Mr. Joseph Pandolfi Vol #: 26
EC 4833 Mrs. Nora Beaulieu Vol #: 26
EC 4834 Mr. Pete Holter Vol #: 26
EC 4835 Mrs. Elisa Giallombardo Vol #: 26
EC 4836 Mrs. Janet Vandegrift Vol #: 26
EC 4837 Mr. Richard Meehan Vol #: 26
EC 4838 Mr. Donald Keefe Vol #: 26
EC 4839 Mr. Frank Boscarillo Vol #: 26
EC 4840 Mrs. Caroline Meehan Vol #: 26
EC 4841 Mr. James Tornatore Vol #: 26
EC 4842 Mrs. Janis Mollman Vol #: 26
EC 4843 Mr. Thomas Bessler Vol #: 26
EC 4844 Mrs. Arlene Borg Vol #: 26
EC 4845 Miss. Jacquelin LaRose Vol #: 26
EC 4846 Mr. Julius Hulstrom Vol #: 26
EC 4847 Mrs. Amberly Tarantina Vol #: 26
EC 4848 Mr. David Orth Vol #: 26
EC 4849 Mr. David Williams Vol #: 26
EC 4850 Mrs. theresa morris Vol #: 26
EC 4851 Mrs. Laurinda Romportl Vol #: 26
EC 4852 Mrs. Cheryl Tedrow Vol #: 26
EC 4853 Mr. Jim Romportl Vol #: 26
EC 4854 Mr. James Costante Vol #: 26
EC 4855 Mrs. Sharon Fischer Vol #: 26
EC 4856 Mrs. Susan Langenkamp Vol #: 26
EC 4857 Ms. Julie Sweet Vol #: 26
EC 4858 Ms. Angela King Vol #: 26
EC 4859 Miss. Ada Merrill Vol #: 26
EC 4860 Mr. Robert Taurence Vol #: 26
EC 4861 Mr. John Junghans Vol #: 26
EC 4862 Mr. Sean Mullarkey Vol #: 26
EC 4863 Dr. Alberto Corrales Vol #: 26
EC 4864 Mrs. Maribeth Gieseke Vol #: 26
EC 4865 Mr. Christopher Seith Vol #: 26
EC 4866 Mr. Richard Cairnes Vol #: 26
EC 4867 Ms. Anna LaBounty Vol #: 26
EC 4868 Mr. Marc McCarthy Vol #: 26
EC 4869 Mrs. Kathleen Esposito Vol #: 26
EC 4870 Mrs. Melissa George Vol #: 26
EC 4871 Mr. James Kozar Vol #: 26
EC 4872 Ms. Amber Kuh Vol #: 26
EC 4873 Dr. william boyd Vol #: 26
EC 4874 Mrs. Peggy DiPrima Vol #: 26
EC 4875 Delaware Right to Life, Inc. Vol #: 26
EC 4876 Ms. Elizabeth Peris Vol #: 26
EC 4877 Miss. Catherine McLeod Vol #: 26
EC 4878 Ms. Bettina Briggs Vol #: 26
EC 4879 Miss. Susan Ashe Vol #: 26
EC 4880 Mrs. ALICE WILLIAMS Vol #: 26
EC 4881 Mrs. Mary Ball Vol #: 26
EC 4882 Mrs. Carol Schofield Vol #: 26
EC 4883 Mr. Michael Renner Vol #: 26
EC 4884 Mrs. Rosemarie Denton R.D.H. Vol #: 26
EC 4885 Ms. Joan Pisoni Vol #: 26
EC 4886 Mr. Peter Smith Vol #: 26
EC 4887 Mrs. Nancy Kenny Vol #: 26
EC 4888 Mr. Joshua Nogales Vol #: 26
EC 4889 Miss. Emily Bissonnette Vol #: 26
EC 4890 Mr. Jon Westerhaus Vol #: 26
EC 4891 Ms. Jonathan Yanta Vol #: 26
EC 4892 Mrs. chris Abel Vol #: 26
EC 4893 Mr. Bill Saccente Vol #: 26
EC 4894 Mrs. Patricia Yanick Vol #: 26
EC 4895 Knights of Columbus Vol #: 26
EC 4896 Mrs. Nancy Beyer Vol #: 26
EC 4897 Mr. Ray DelMastro Vol #: 26
EC 4898 Mr. James Rice Vol #: 26
EC 4899 Mrs. Sarah Russo Vol #: 26
EC 4900 Mercy Hospital Physical Therapy Vol #: 26
EC 4901 Ms. Andrea Lewis Vol #: 26
EC 4902 Mrs. Leslie Fairchild Vol #: 26
EC 4903 Knights of Columbus Respect for Life Committee Vol #: 26
EC 4904 Dr. Paddy Spencer Vol #: 26
EC 4905 Mr. David and Maria Buerkle Vol #: 26
EC 4906 Mrs. Camille Dalton Vol #: 26
EC 4907 Mrs. Frances H. Van de Voorde Vol #: 26
EC 4908 Miss. Kelly Smith Vol #: 26
EC 4909 Mr. Trevor Lambert Vol #: 26
EC 4910 Mrs. Mary Karen Solinger Vol #: 26
EC 4911 Mr. joseph schuessler Vol #: 26
EC 4912 Mr. Joseph Steffl Vol #: 26
EC 4913 Mr. Nathan Lewis Vol #: 26
EC 4914 Mr. John and Lori Ginzel Vol #: 26
EC 4915 Mr. Mike Keeney Vol #: 26
EC 4916 Ms. Susanne Moskalski Vol #: 26
EC 4917 Mrs. Tina Guth Vol #: 26
EC 4918 Mississippi State Council - Knights of Columbus Vol #: 26
EC 4919 Mrs. Colette Hagen Vol #: 26
EC 4920 Mrs. Paula Niksa Vol #: 26
EC 4921 Mr. Gregory Molnar Vol #: 26
EC 4922 none Vol #: 26
EC 4923 Ms. Bonnie Miller-Baez, LVN Vol #: 26
EC 4924 Mr. Dennis Nordhoff Vol #: 26
EC 4925 Mrs. Jo Ann Nordhoff Vol #: 26
EC 4926 NONE Vol #: 26
EC 4927 Mr. Michael Fischer Vol #: 26
EC 4928 Mrs. Kathleen Barr Vol #: 26
EC 4929 Mrs. Mary Beth Style Vol #: 26
EC 4930 Mr. George V. Ahrens Vol #: 26
EC 4931 Ms. Linda Baez Vol #: 26
EC 4932 Mrs. Margaret Disney Vol #: 26
EC 4933 Mrs. gail ellis Vol #: 26
EC 4934 Dr. Ann Barta Vol #: 26
EC 4935 Mr. Paul Tourigny Vol #: 26
EC 4936 Mrs. Christine Shiiba Vol #: 26
EC 4937 Mrs. Jennifer Davey Vol #: 26
EC 4938 Mr. Craig Barta Vol #: 26
EC 4939 Mr. Dean Weiss Vol #: 26
EC 4940 Dr. Mary Mariska Vol #: 26
EC 4941 Mr. Luke Van de Voorde Vol #: 26
EC 4942 Mrs. chris mcdonald Vol #: 26
EC 4943 Mrs. Jamie Helbling Vol #: 26
EC 4944 Mr. James Burrows Vol #: 26
EC 4945 Ms. Susannah Gavin-Laing Vol #: 26
EC 4946 Mrs. Catherine Caputo Vol #: 26
EC 4947 Mr. Cuong Thai Vol #: 26
EC 4948 Miss. Joanne Kunz Vol #: 26
EC 4949 Mr. Mark Miller Vol #: 26
EC 4950 Mrs. Helen Gray Vol #: 26
EC 4951 Mrs. Janene Wuchterl Vol #: 26
EC 4952 Mrs. Angela Kusmitch Vol #: 26
EC 4953 Mrs. Audrey Piepmeier Vol #: 26
EC 4954 Catholic Vol #: 26
EC 4955 Mr. Eric Piepemeier Vol #: 26
EC 4956 Mr. Peter Molnar Vol #: 26
EC 4957 Mrs. Ethel Borel-Donohue Vol #: 26
EC 4958 Mr. James Gardner Vol #: 26
EC 4959 Mr. Alan Johnson Vol #: 26
EC 4960 Mrs. SUSAN DEJONG Vol #: 26
EC 4961 Mrs. Jenna ragsdale Vol #: 26
EC 4962 Mr. Daniel Cosgrove Vol #: 26
EC 4963 Mrs. Mary Hodge Vol #: 26
EC 4964 Mr. William Gourley Vol #: 26
EC 4965 Mrs. Mary Sadick Vol #: 26
EC 4966 Pro Life Committee Chair Vol #: 26
EC 4967 Dr. Robert Pearson Vol #: 26
EC 4968 Human Race Vol #: 26
EC 4969 Mrs. Susan Holmquist Vol #: 26
EC 4970 Mrs. Amanda Frasier Vol #: 26
EC 4971 Mrs. Jane Young Vol #: 26
EC 4972 Mrs. Carolyn Stenger Vol #: 26
EC 4973 Mrs. Kekette Jurchak Vol #: 26
EC 4974 Delaware Family Foundation Vol #: 26
EC 4975 Advanced Wellness Vol #: 26
EC 4976 Mrs. Joanne Southers Vol #: 26
EC 4977 Mrs. Denae Bowen Vol #: 26
EC 4978 Theology of the Body International Alliance Vol #: 26
EC 4979 Miss. Carolyn Marcello Vol #: 26
EC 4980 Mrs. Leann Lolli Vol #: 26
EC 4981 Mrs. Rebecca Dixon Vol #: 26
EC 4982 Mrs. Sharon Brightfield Vol #: 26
EC 4983 Mrs. Jennifer Applebee Vol #: 26
EC 4984 Miss. Alicia Morse Vol #: 26
EC 4985 Mrs. Mary Brutsche Vol #: 26
EC 4986 Mr. wayne Hoffman Vol #: 26
EC 4987 Mr. Geoff Pearson Vol #: 26
EC 4988 Mrs. Barbara Wrzesinski Vol #: 26
EC 4989 Mr. Ted Sasse Vol #: 26
EC 4990 Mrs. Carol Krystosek Vol #: 26
EC 4991 Mrs. Julie Weoge; Vol #: 26
EC 4992 Mrs. Kathryn Kirby Vol #: 26
EC 4993 Dr. Steven Gulding Vol #: 26
EC 4994 CCL/grand traverse co. Vol #: 26
EC 4995 Mrs. Eleanor Kunz Vol #: 26
EC 4996 Mr. steve perdue Vol #: 26
EC 4997 Mr. Fidelis Ceranski Vol #: 26
EC 4998 Mrs. Kathy Murphy Vol #: 26
EC 4999 Mrs. Peggy Wojcik Vol #: 26
EC 5000 Mr. Kurt Wolfe Vol #: 26
EC 5001 Mrs. Kathryn Schroeder Vol #: 26
EC 5002 Ms. Kathryn Morse Vol #: 26
EC 5003 Dr. Mike Schroeder Vol #: 26
EC 5004 RC Church Vol #: 26
EC 5005 Mrs. Anne Spalding Vol #: 26
EC 5006 Mrs. Stephanie Andrus Vol #: 26
EC 5007 Mrs. Janna Sasse Vol #: 26
EC 5008 Mrs. Jeanne Dart Vol #: 26
EC 5009 Ms. Corrie Duran Vol #: 26
EC 5010 Dr. Roy Kerlin Vol #: 26
EC 5011 N/A Vol #: 26
EC 5012 Dr. Robin Kerlin Vol #: 26
EC 5013 Mrs. Nancy Calvin Vol #: 26
EC 5014 Mrs. Christine Bolio, RN Vol #: 26
EC 5015 Mr. Woodrow Rhea Vol #: 26
EC 5016 Mrs. Melissa Woulfe Vol #: 26
EC 5017 Our Lady of Lourdes CAtholic Church Vol #: 26
EC 5018 Mr. Cletus J Tauer Vol #: 26
EC 5019 Mrs. Andrea Brown Vol #: 26
EC 5020 Mr. John Krock Vol #: 26
EC 5021 Dr. Martin Tohill Vol #: 26
EC 5022 Mrs. Judith Badami Vol #: 26
EC 5023 Mr. Mark Mariska Vol #: 26
EC 5024 Mr. William Cornell Vol #: 26
EC 5025 Ms. Mary Jane Owen Vol #: 26
EC 5026 Mrs. Patty Green Vol #: 26
EC 5027 Mrs. Debbie Stefan Vol #: 26
EC 5028 Mrs. Melanie Bruyers Vol #: 26
EC 5029 Ms. Linda Shellenbarger Vol #: 26
EC 5030 Mr. Charles Green Vol #: 26
EC 5031 Citizen Vol #: 26
EC 5032 Mrs. Denise Faugot Vol #: 26
EC 5033 Mr. albert niebergall Vol #: 26
EC 5034 Mrs. Maria Gillcrist Vol #: 26
EC 5035 Mrs. Jennifer Norene Vol #: 26
EC 5036 Mrs. Lori Burkhart Vol #: 26
EC 5037 Ms. patricia taylor Vol #: 26
EC 5038 Mrs. Catherine Hansen, R.N. Vol #: 26
EC 5039 Mrs. Kathleen Basil Vol #: 26
EC 5040 Mrs. Sandy Schneider Vol #: 26
EC 5041 Human Life International Vol #: 26
EC 5042 Mrs. Patricia DiPietro Vol #: 26
EC 5043 Mrs. Christine Hohreiter Vol #: 26
EC 5044 Miss. Kristina Halfpap OTR/L Vol #: 26
EC 5045 Miss. Lesley Rice Vol #: 26
EC 5046 Mrs. Anne Blom Vol #: 26
EC 5047 Mr. tom rich Vol #: 26
EC 5048 Mr. Colm y Muireagyin Vol #: 26
EC 5049 Mrs. Theresa Eicher Vol #: 26
EC 5050 Mr. John Egan Vol #: 26
EC 5051 Pediatric Alliance Vol #: 26
EC 5052 Mrs. Celeste Epstein Vol #: 26
EC 5053 Ms. Margaret Howell Vol #: 26
EC 5054 Mr. John Thompson Vol #: 26
EC 5055 Mr. George Barth Vol #: 26
EC 5056 Mr. Brian Byrne Vol #: 26
EC 5057 None Vol #: 26
EC 5058 Mrs. Mary Ann Sweeney Vol #: 26
EC 5059 Mr. Ralph Hoffer Vol #: 26
EC 5060 Mrs. Anne Broussard Vol #: 26
EC 5061 Mrs. Janet Herlihey Vol #: 26
EC 5062 Mr. Pasqual Battaglia Vol #: 26
EC 5063 Miss. Audrey Dandoy Vol #: 26
EC 5064 Mrs. Drucella Faulk Vol #: 26
EC 5065 Ms. Veronica Kopf Vol #: 26
EC 5066 Pro life church committee chairwoman Vol #: 26
EC 5067 Shanley's Home Improvements Vol #: 26
EC 5068 Mrs. julia lintz Vol #: 26
EC 5069 Mr. joel pawletzki Vol #: 26
EC 5070 All God's omfort Prayer Ministry Vol #: 26
EC 5071 Mrs. Jo Ann Gerling Vol #: 26
EC 5072 Mrs. Allison Girone Vol #: 26
EC 5073 Ms. Kathy Radosevich Vol #: 26
EC 5074 Mrs. Kathleen Darcy Vol #: 26
EC 5075 Mrs. Jomary Chenet Vol #: 26
EC 5076 Ms. Teresa Huang Vol #: 26
EC 5077 Mrs. Victoria Sheridan Vol #: 26
EC 5078 Ms. Theresa Hofer Vol #: 26
EC 5079 Mrs. Cindy Whitney Vol #: 26
EC 5080 Mrs. Deborah Frederick Vol #: 26
EC 5081 Ms. Megan Gaughan Vol #: 26
EC 5082 Mrs. Amy Monaghan Vol #: 26
EC 5083 Mrs. Brenda Steffl Vol #: 26
EC 5084 Mr. Thomas Livorsi Vol #: 26
EC 5085 Mrs. Sandra Black Vol #: 26
EC 5086 Mrs. Pam Ahearn Vol #: 26
EC 5087 Ms. Suzanne Faulks-Fortunato Vol #: 26
EC 5088 Mrs. Robert D. Caputi Vol #: 26
EC 5089 Mrs. Amanda Thille Vol #: 26
EC 5090 Mr. Joseph Stano Vol #: 26
EC 5091 Mrs. Elizabeth Papandrea Vol #: 26
EC 5092 Ms. Melissa Hackenmueller Vol #: 26
EC 5093 Mrs. Cynthia Bockhold Vol #: 26
EC 5094 Mrs. Jeanne Hackenmueller Vol #: 26
EC 5095 Mrs. jenifer Latawiec Vol #: 26
EC 5096 Mrs. Vicky Wolfe Vol #: 26
EC 5097 Mrs. Marilyn Loegering Vol #: 26
EC 5098 Ms. Josia Martin Vol #: 26
EC 5099 Mr. Mike Meziere Vol #: 26
EC 5100 Dr. Timothy Lock Vol #: 26
EC 5101 Mr. David Nelson Vol #: 26
EC 5102 Mr. Rodolfo Mora Vol #: 26
EC 5103 Mrs. Erin Salter Vol #: 26
EC 5104 Mrs. Leanne Seguin Vol #: 26
EC 5105 Mr. George Loegering Vol #: 26
EC 5106 Mr. Aaron Salter Vol #: 26
2006N-0292 Unique Device Identification
C 27 Orthopedic Surgical Manufacturers Association (OSMA) Vol #: 8
C 28 Healthcare Distribution Management Association (HDMA) Vol #: 8
2006N-0465 Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting
EC 1 ForHealth Technologies, Inc. Vol #: 1
2006P-0390 Order the Church of Scientology to clearly disclose the potential health hazards inherent in the use of the E-meter and Scientology's practice of "auditing"
EC 17 Mr. Jerry Staton Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
EC 455 Mrs. Heather Gonzales Vol #: 7
EC 456 Ms. Paula Sonney Vol #: 7
2006P-0415 Petition Seeking Regulation of Cloned Animals
C 4 M. Gardan Vol #: 2
C 5 D. Finger Vol #: 2
C 6 P. Joralemon Vol #: 2
EC 6 Ms. Denise Brander Vol #: 2
EC 7 Ms. Mary Donovan Vol #: 2
EC 8 N/A Vol #: 2
EC 9 Mrs. Reyna Walsh Vol #: 2
EC 10 Mrs. Pam Bianco Vol #: 2
EC 11 Mr. Robert Reuer Vol #: 2
EC 12 Miss. Lisa Fennell Vol #: 2
EC 13 United States Citizen Vol #: 2
EC 14 Miss. halyn hughes Vol #: 2
EC 15 Mr. John Tarantino Vol #: 2
2006P-0508 Make 2 to 5 milligram pills of Naltrexone to have over-the-counter status
C 1 C. Weber Vol #: 1
2006P-0522 Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD
EC 1 Mr. Dave Lowe Vol #: 1
2006P-0535 Ban From all Medicine and Vaccines Thimerosal or any Other Mercury-based Compound Products
ACK 1 FDA/DDM to CoMed, Coalition for Mercury-Free Drugs Vol #: 1
CP 1 CoMed, Coalition for Mercury-Free Drugs Vol #: 1
LET 1 FDA/OC to CoMed, Coalition for Mercury-Free Drugs Vol #: 1

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