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Dockets Management

Dockets Entered On November 16, 2006
Docket # Title
1978N-0065 Skin Bleaching Drug Products
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
2004D-0198 Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
2005N-0374 Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
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
2006F-0409 Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
2006N-0107 FDA-Regulated Products Containing Nanotechnology Materials
2006N-0292 Unique Device Identification
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
2006P-0094 To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
2006P-0371 Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
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
1978N-0065 Skin Bleaching Drug Products
EC 17 Ms. Babette deWall Vol #: 4
EC 18 Miss. Diedra Hicks Vol #: 4
EC 19 Dr. andrea Garrett Vol #: 4
EC 20 American Society of Dermatologic Surgeons Vol #: 4
EC 21 Dr. Glenda Swetman Vol #: 4
EC 22 Emmanuel R. Loucas, M.D. P.C. Vol #: 4
EC 23 Dr. Allison Stocker Vol #: 4
EC 24 University of Pittsburgh Vol #: 4
EC 25 Hershey Medical Center Vol #: 4
EC 26 Dr. Oswald Mikell Vol #: 4
EC 27 Hershey Medical Center Vol #: 4
EC 28 ASDS (American Society for Dermatologic Surgery) Vol #: 4
EC 29 Asst. Clinical Professor, SUNY Downstate Med. Ctr. Vol #: 4
EC 30 Dr. Zoe Friedman Vol #: 4
EC 31 Oregon Health and Science University Vol #: 4
EC 32 Dr. Larisa Ravitskiy Vol #: 4
EC 33 University of Missouri - Columbia Vol #: 4
EC 34 ASDS Vol #: 4
EC 35 Dr. Liliana Saap Vol #: 4
EC 36 American Society for Dermatologic Surgery Vol #: 4
EC 37 Dr. David Van dam Vol #: 4
EC 38 Dr. Monica Trail Vol #: 4
EC 39 Dr. Steven Simon Vol #: 4
EC 40 University of Pennsylvania Health System Vol #: 4
EC 41 Dr. Bruce Berger Vol #: 4
EC 42 Dr. Elie Levy Vol #: 4
EC 43 Dr. Jennifer Krejci-Manwaring Vol #: 4
EC 44 Dr. Joel Schlessinger Vol #: 4
EC 45 Dr. joyce lim Vol #: 4
EC 46 Amer Acad of Dermatology Vol #: 4
EC 47 UCSF Dept of Dermatology Vol #: 4
EC 48 Dr. Melissa Lazarus Vol #: 4
EC 49 Dr. Kevin Crawford Vol #: 4
2003D-0478 Guidance on Marketed Unapproved Drugs Compliance Policy Guide
EC 37 BLANSETT PHARMACAL CO., INC. Vol #: 5
2004D-0198 Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components
EC 5 Mr. Jack Proctor Vol #: 1
2005N-0374 Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
C 11 K. ALlen Vol #: 1
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
C 2 Allergen Products Maufacturers Association Vol #: 3
2006D-0344 Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling
EMC 5 Amgen Regulatory Affairs 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
C 50 R. McGlinchey Vol #: 7
C 51 A. WAring Vol #: 7
C 52 Mr and Mrs R. Bisset Vol #: 7
C 53 M. Marinoni Vol #: 7
C 54 J. McLean, BSc, MD Vol #: 7
C 55 M and K Schoettmer Vol #: 7
C 56 R,L,J and M Holmes Vol #: 7
C 57 C. Sodowsky, R.N. Vol #: 7
C 58 Dr. D. Perrella Vol #: 7
C 59 S and D McEnery Vol #: 7
C 60 P. Velez Vol #: 7
C 61 M. Lenthe, RN Vol #: 7
C 62 C. Emons Vol #: 7
C 63 M. Lacek Vol #: 7
C 64 L. Levin Vol #: 7
C 65 C. Steams Vol #: 7
C 66 J. Otrembiak Vol #: 7
C 67 S. Lunt Vol #: 7
C 68 C. George, RN, BSN Vol #: 7
C 69 T. LeSage Vol #: 7
C 70 T. Flick, RN, BSN, BA Vol #: 7
C 71 K. DeSmet Vol #: 7
C 72 T and K Cunningham Vol #: 7
C 73 Y. Tenorio Vol #: 7
C 74 L. Maes Vol #: 7
C 75 L. Squarzini Vol #: 7
C 76 M. Szechenyi Vol #: 7
C 77 W. Makeeff Vol #: 7
C 78 F. Doris Vol #: 7
C 79 R. Liwanag Vol #: 7
C 80 M. Ward Vol #: 7
EC 1721 Mrs. Tammy Roquebert Vol #: 6
EC 1722 Mrs. Marianne Hospador Vol #: 6
EC 1723 Mrs. Karen Beyer Vol #: 6
EC 1724 Mrs. Mary Schmiesing Vol #: 6
EC 1725 Mrs. Donna Davis Vol #: 6
EC 1726 Ms. Norma Thomas Vol #: 6
EC 1727 Ms. Mary Root Vol #: 6
EC 1728 Mr. Keith Entzeroth Vol #: 6
EC 1729 Miss. Jacinta Whittaker Vol #: 6
EC 1730 Mrs. Laura Nolan Vol #: 6
EC 1731 Ms. Gilda Bares Vol #: 6
EC 1732 Mrs. Camilla Stevens Vol #: 6
EC 1733 Mrs. Ann Burt Vol #: 6
EC 1734 Mr. John MacAlister Vol #: 6
EC 1735 Mrs. Molly Rudy Vol #: 6
EC 1736 Mrs. Maureen McKeough Vol #: 6
EC 1737 The Fathers of Mercy Vol #: 6
EC 1738 Mrs. Melissa Clement Vol #: 6
EC 1739 Mrs. Linda Bailes Vol #: 6
EC 1740 Ms. Shelley Stanzel Vol #: 6
EC 1741 None Vol #: 6
EC 1742 Ms. Esther Middleton Vol #: 6
EC 1743 none Vol #: 6
EC 1744 Mrs. Susan Smith Vol #: 6
EC 1745 Mr. Mat Burt Vol #: 6
EC 1746 Mrs. Janet Zazulak Vol #: 6
EC 1747 Mrs. MarieFrance Morris Vol #: 6
EC 1748 Mrs. Catherine Saccente Vol #: 6
EC 1749 Ms. Ruby Schuetz Vol #: 6
EC 1750 Mrs. Denise Puckett Vol #: 6
EC 1751 Mrs. Colleen Carey Vol #: 6
EC 1752 Ms. Frances Cortinas Vol #: 6
EC 1753 Mrs. Jean Reilly Vol #: 6
EC 1754 CONCERNED CITIZEN Vol #: 6
EC 1755 Mr. David Hasser Vol #: 6
EC 1756 Mrs. Cheryl Watson Vol #: 6
EC 1757 Mrs. susan paul Vol #: 6
EC 1758 Mrs. LLOYD Schreiber Vol #: 6
EC 1759 Ms. Emily Brown Vol #: 6
EC 1760 Ms. Marie Schade-Wood Vol #: 6
EC 1761 Mrs. Margie Klement Vol #: 6
EC 1762 Mrs. Carol Seward Vol #: 6
EC 1763 Ms. Karen Nickels Vol #: 6
EC 1764 Mrs. Bernadette Myers Vol #: 6
EC 1765 Mr. Gregory Bramlet Vol #: 6
EC 1766 Mrs. Lynn Flaherty Vol #: 6
EC 1767 Miss. Dawn Pauldine Vol #: 6
EC 1768 Mrs. Dori Cantrell Vol #: 6
EC 1769 Mr. Raymond Franklin Vol #: 6
EC 1770 Live Oak Academy Vol #: 6
EC 1771 Mrs. Tracy Attar Vol #: 6
EC 1772 Mrs. Tracie Huber Vol #: 6
EC 1773 Mrs. Jennifer Valley Vol #: 6
EC 1774 Mrs. mary robertson Vol #: 6
EC 1775 none Vol #: 6
EC 1776 Ms. elizabeth muir Vol #: 6
EC 1777 Mrs. Deborah Valley Vol #: 6
EC 1778 Miss. Joan Watson Vol #: 6
EC 1779 Catholic Charities USA Vol #: 6
EC 1780 Mrs. Kinden Heitschmidt Vol #: 6
EC 1781 professional mom Vol #: 6
EC 1782 Mrs. Margaret Nicholas Vol #: 6
EC 1783 Mrs. Diane Jabaley Vol #: 6
EC 1784 Ms. Maxanne Durkee Vol #: 6
EC 1785 Mrs. Caroline Elliott Vol #: 6
EC 1786 Mrs. Annette Lorenzen Vol #: 6
EC 1787 Mrs. Wendy Pavlat Vol #: 6
EC 1788 Mrs. Morag Marinoni Vol #: 6
EC 1789 Mrs. Theresa Weessies Vol #: 6
EC 1790 Mr. Joel Learner Vol #: 6
EC 1791 Mrs. Regina Eufinger Vol #: 6
EC 1792 Mrs. Jeanie Schmitz Vol #: 6
EC 1793 Mr. Steve Busch Vol #: 6
EC 1794 Mrs. Laurie Joyce Vol #: 6
EC 1795 catholic women's league , st. patrick's, mississau Vol #: 6
EC 1796 Mrs. Calandra Koester Vol #: 6
EC 1797 Ms. Shalini Trehan Vol #: 6
EC 1798 CANADA SILENT NO MORE Vol #: 6
EC 1799 Mr. vincent silveri Vol #: 6
EC 1800 Mr. Juan Jorge Vol #: 6
EC 1801 Miss. Susan Torres Vol #: 6
EC 1802 Mrs. Sylvia Abrahamson Vol #: 6
EC 1803 Mrs. julia becker Vol #: 6
EC 1804 Mr. Ken Jacobson Vol #: 6
EC 1805 Mrs. Agnes R Hartmann Vol #: 6
EC 1806 Mr. Steven Gonzalez Vol #: 6
EC 1807 Ms. Nancy Jordan Vol #: 6
EC 1808 Mr. John Brondello Vol #: 6
EC 1809 Mrs. Ann Slattery Vol #: 6
EC 1810 Mr. Brian Geffre Vol #: 6
EC 1811 Mr. Don Schutt Vol #: 6
EC 1812 Private Citizen Vol #: 6
EC 1813 Mrs. Theresa Thomas Vol #: 6
EC 1814 Mr. GREG KLEIN Vol #: 6
EC 1815 Mr. Alexander Thomson Vol #: 6
EC 1816 Mrs. Maria Wills Vol #: 6
EC 1817 Ms. Barbara Chall Vol #: 6
EC 1818 Mrs. Mary Weis Vol #: 6
EC 1819 Mrs. Dawn Jackson Vol #: 6
EC 1820 Catholics Respect Life Vol #: 6
EC 1821 Mrs. Marie Hudyma Vol #: 6
EC 1822 Mrs. Wanda Gowring Vol #: 6
EC 1823 Mr. James M. McSharry Vol #: 6
EC 1824 Ms. Jean Farrell Vol #: 6
EC 1825 Mrs. Mary Nelson Vol #: 6
EC 1826 n/a Vol #: 6
EC 1827 Mrs. Nancy McNulty Vol #: 6
EC 1828 Mrs. Debra Snyder Vol #: 6
EC 1829 Mrs. Joan Andersen Vol #: 6
2006F-0409 Safe Use of Cetylpyridinium Chloride as an Antimicrobial Agent in a Pre-chiller or Post-chiller Solution for Application to Raw Poultry Carcasses (FAP 6A4767)
C 1 No signature Vol #: 1
EC 1 Case Farms Vol #: 1
2006N-0107 FDA-Regulated Products Containing Nanotechnology Materials
C 15 J. Hollenberg Vol #: 12
2006N-0292 Unique Device Identification
C 19 America's Health Insurance Plans (AHIP) Vol #: 8
C 20 Summa Health System Vol #: 8
C 21 Avera Marshall Regional Medical Center Vol #: 8
C 22 Pipestone County Medical Center Vol #: 8
C 23 Mississippi Baptist Health System Vol #: 8
C 24 Baptist Health System, Inc. Vol #: 8
C 25 American Association of Orthopaedic Surgeons (AAOS) Vol #: 8
C 26 Health Industry Distributors Association (HIDA) Vol #: 8
2006N-0352 Comments Relating to the September 6 & 7, 2006 Joint Panel Meeting on Dental Amalgam
C 45 G. Bragiel Vol #: 25
C 46 C. Bender Vol #: 25
C 47 L. Foster Vol #: 25
C 48 W. Webb Vol #: 25
C 49 W. Webb Vol #: 25
C 50 N. Oakes Vol #: 25
C 51 W. Webb Vol #: 25
C 52 W. Webb Vol #: 25
C 53 G. Edwards, DMD Vol #: 25
C 54 S. Levine Vol #: 25
C 55 S. Markus, D.M.D., F.A.C.E. Vol #: 25
C 56 L. Nagy, MD Vol #: 25
C 57 S. White Vol #: 25
C 58 T. Bolton Vol #: 25
C 59 R. Richardson Vol #: 25
C 60 Dr. J. Snively & S. Anima Vol #: 25
C 61 M. Gossweiler, D.D.S. et al Vol #: 25
C 62 J. Gruber Vol #: 25
C 63 R. Olson, DDS Vol #: 25
C 64 Health Advocacy in the Public Interest Vol #: 25
C 65 Health Advocacy in the Public Interest Vol #: 25
C 66 B. Sage Vol #: 25
C 67 L. Deutsch Vol #: 25
C 68 J. Saltzman Vol #: 25
C 69 R. Petro Vol #: 25
C 70 S. Bucha Vol #: 25
C 71 S. Scheckner, DMD Vol #: 25
C 72 L. Ramos Vol #: 25
C 73 D. Davis Vol #: 25
C 74 S. Waserman Vol #: 25
C 75 L. Houle Vol #: 25
C 76 L. Stevens Vol #: 25
C 77 G. Wells Vol #: 25
C 78 J. Grossman Vol #: 25
C 79 B. Lynch, BS, ND Vol #: 25
C 80 P. Anderson Vol #: 25
C 81 Dr. J. Lewis, PhD Vol #: 25
C 82 Jigsaw Health Foundation Vol #: 25
C 83 R. Clarke Vol #: 25
C 84 M. Carter Vol #: 25
C 85 P. Finch Vol #: 25
C 86 R. Kulacz, DDS Vol #: 25
C 87 J. Baunach Vol #: 25
C 88 B. Crowell Vol #: 25
C 89 Children's Health Environmental Coalition (CHEC) Vol #: 25
C 90 J. Marich Vol #: 25
C 91 J. Gianoli Vol #: 25
C 92 M. Ortega Vol #: 25
C 93 E. Jesman Vol #: 25
C 94 E. Pickett Vol #: 25
C 95 R. Corrigan Vol #: 25
C 96 M. Albert Vol #: 25
C 97 M. Jones Vol #: 25
C 98 S. Bierker Vol #: 25
C 99 C. Tomashofski Vol #: 25
C 100 L. Weaver Vol #: 25
C 101 P. Lindsay Vol #: 25
C 102 C. Vincent Vol #: 25
C 103 C. Impellizzeri Vol #: 25
C 104 C. McCabe Vol #: 25
C 105 M. Skeels Vol #: 25
C 106 B. Shands Vol #: 25
C 107 S. Schnall Vol #: 25
C 108 N. Kennedy Vol #: 25
C 109 T. Elliott Vol #: 25
C 110 B. Spittle Vol #: 25
C 111 Consumers for Dental Choice Vol #: 25
C 112 C. Pishdad Vol #: 25
C 113 L. Werner Vol #: 25
TR 1 Transcript of the Joint Meeting of Dental Products Panel and Central Nervous System Drugs Advisory Vol #: 21
TR 2 Transcript of the Joint Meeting of Dental Products Panel and Central Nervous System Drugs Advisory Vol #: 22
2006P-0094 To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
C 4 Corn Refiners Association (CRA) Vol #: 2
2006P-0371 Immediately add a black box warning regarding the risks of tendinopathy and tendon rupture to the product labels of all fluoroquinolone antibiotics presently on the market in the United States
EC 7 Ms. Billie Johnson Vol #: 1
EC 8 Mrs. Tiffany Rose Vol #: 1
EC 9 Santa Clara In-Home Support Services 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 14 Mr. Jerry Staton Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
EC 406 Ms. Amanda Schumacher Vol #: 7
EC 407 Mr. Sergio Moncada Vol #: 7
EC 408 Ms. Jennadee Bishop Vol #: 7

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