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Dockets Management

Dockets Entered On August 29, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
1998D-0077 Treatment of osteoarthritis/drugs, devices and biological pt
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
2006N-0067 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
2006N-0420 Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0307 To amend 21CFR 201.17 regarding expiration dates
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2006P-0496 Determine whether Sulfamethoxazole, Trimethoprim, and Phenazopyride HCI, have been voluntarily withdrawn or withheld for safety or efficacy reasons
2006P-0505 ANDA for Ursodial Capsules USP, 100 mg 200 mg, and 400 mg
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
2007D-0213 Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
2007D-0310 Companion to Guidance for Industry on Pharmacogenomic Data
1978N-0038 Sunscreen Drug Products
EC 1918 Mr. Danny Parris Vol #: 160
EC 1919 Ms. janet young Vol #: 160
EC 1920 Ms. Heather Stanley Vol #: 160
EC 1921 Mrs. Pamela Schmidt Vol #: 160
EC 1922 Ms. Melissa Forbes Vol #: 160
EC 1923 Mr. Robert Heilman Vol #: 160
EC 1924 Mrs. Erin Scharer Vol #: 160
EC 1925 Ms. Jennifer Wiley Vol #: 160
EC 1926 Mrs. Jaclyn Hubbart Vol #: 160
EC 1927 Mr. Benoni Outerbridge Vol #: 160
EC 1928 Ms. Molli Hoos Vol #: 160
EC 1929 Ms. Tamera Standage Vol #: 160
EC 1930 public administration Vol #: 160
EC 1931 Mrs. Lisa Carroll Vol #: 160
EC 1932 Ms. Liz Sigel Vol #: 160
EC 1933 Ms. Julianne Bryant Vol #: 160
EC 1934 Ms. Brenda Songy Vol #: 160
EC 1935 Dr. Allison Dixon Vol #: 160
EC 1936 Dr. Stephenie Riley Vol #: 160
EC 1937 Ms. Brenna Norton Vol #: 160
EC 1938 Mrs. Margot Mahoney Vol #: 160
EC 1939 Ms. Tara Verma Vol #: 160
EC 1940 Ms. Pilar bauta Vol #: 160
EC 1941 Ms. Linda Dellett Vol #: 160
EC 1942 Mrs. Heather Murawski Vol #: 160
EC 1943 Burt Township School Vol #: 160
EC 1944 Mr. Jon Marchant Vol #: 160
EC 1945 Ms. Melissa Bryan Vol #: 160
EC 1946 Mr. Anthony McNulty Vol #: 160
EC 1947 Mrs. Mindy Waitkus Vol #: 160
EC 1948 Mrs. Darrah Barry Vol #: 160
EC 1949 Ms. Nicole McKenzie Vol #: 160
EC 1950 Miss. Loreen Harvey Vol #: 160
EC 1951 Miss. Janelle Kuhn Vol #: 160
EC 1952 Mrs. Darla Kasiske Vol #: 160
EC 1953 Miss. Leslie Kancir Vol #: 160
EC 1954 Ms. Laurel Earnshaw Vol #: 160
EC 1955 Ms. nancy martin-silber Vol #: 160
EC 1956 Ms. Lisa de Vincent Vol #: 160
EC 1957 Mr. Thomas Skadow Vol #: 160
EC 1958 Mrs. Penny Long Vol #: 160
EC 1959 Ms. Elizabeth M. Ferranti Vol #: 160
EC 1960 Mrs. Norma Joslin Vol #: 160
EC 1961 Mrs. KATHLEEN RAMIREZ Vol #: 160
EC 1962 Mr. JOHN CURIEL Vol #: 160
EC 1963 Mr. david conley Vol #: 160
EC 1964 Mrs. Lorraine Valentine Vol #: 160
EC 1965 Mrs. Michelle Daly Vol #: 160
EC 1966 Ms. Kimberly Phillips Vol #: 160
EC 1967 Miss. Rachelle Greene Vol #: 160
EC 1968 Mr. William Kleist Vol #: 160
EC 1969 Miss. Jessica Bangs Vol #: 160
EC 1970 Ms. Deborah Dow-Gallagher Vol #: 160
EC 1971 Mrs. LInda Roush Vol #: 160
EC 1972 Mrs. Marcia Delgadillo Vol #: 160
EC 1973 Ms. Susan MacCaul Vol #: 160
EC 1974 Mr. W. Scott Cook Vol #: 160
EC 1975 Dr. Kathleen Smith Vol #: 160
EC 1976 Mr. Jeffrey O'Sheil Vol #: 160
EC 1977 Miss. Deana Taylor Vol #: 160
EC 1978 individulal Vol #: 160
EC 1979 Mrs. angela ehrich Vol #: 160
EC 1980 AMA Vol #: 160
EC 1981 Ms. Maura Fitzgerald Vol #: 160
EC 1982 Mrs. Ginger Yancey Vol #: 160
EC 1983 Ms. Jennifer Jordan Vol #: 160
EC 1984 San Diego ElderCare Vol #: 160
EC 1985 Mr. Stephen Kless Vol #: 160
EC 1986 Mr. Hans Kriek Vol #: 160
EC 1987 Mrs. Ann Parziale Vol #: 160
EC 1988 Mr. John Murphy Vol #: 160
EC 1989 Ms. Paula Ganstine Vol #: 160
EC 1990 Ms. Cecily McGaw Vol #: 160
EC 1991 Mrs. Linda Treese Vol #: 160
EC 1992 Ms. Paola Solorzano Vol #: 160
EC 1993 Ms. Erin Mandell Vol #: 160
EC 1994 Ms. Nancy Gingerich Vol #: 160
EC 1995 Mrs. Olivia Christianson Vol #: 160
EC 1996 Ms. Lisa Sniderman Vol #: 160
EC 1997 Ms. Karen Knispel Vol #: 160
EC 1998 Mr. Pierre Black Vol #: 160
EC 1999 Ms. Annie Yew Vol #: 160
EC 2000 Mrs. Christina Dobrik Vol #: 160
EC 2001 Mr. Simon Thomas Vol #: 160
EC 2002 NONE Vol #: 160
EC 2003 Mrs. C Smith Vol #: 160
EC 2004 Ms. Shannon Mentzer Vol #: 160
EC 2005 Ms. Susan Baer Vol #: 160
EC 2006 Dr. Mark Richards Vol #: 160
EC 2007 Mrs. Michelle Naill Vol #: 160
EC 2008 Mrs. Christian Marcotte Vol #: 160
EC 2009 Ms. Christine Mersand Vol #: 160
EC 2010 Ms. Janet Marcus Vol #: 160
EC 2011 Mrs. Terry Ern Vol #: 160
EC 2012 Ms. Kimbally Hewitt Vol #: 160
EC 2013 Mrs. Deborah Hueser Vol #: 160
EC 2014 Ms. Brandi Herricks Vol #: 160
EC 2015 Mrs. Sandi Echelle Vol #: 160
EC 2016 Ms. Lauren Ditz Vol #: 160
EC 2017 Mr. John Schuler Vol #: 160
EC 2018 Ms. Louise Jeffrey Vol #: 160
EC 2019 Ms. Linda Schneider Vol #: 160
EC 2020 Miss. Phoebe Bull Vol #: 160
EC 2021 Ms. Pauline Short Vol #: 160
EC 2022 Ms. Susie Vader Vol #: 160
EC 2023 Ms. Kandace Bernal Vol #: 160
EC 2024 Ms. Amanda Guay Vol #: 160
EC 2025 Ms. Shira Shazeer Vol #: 160
EC 2026 Mrs. Kristen Rockford Vol #: 160
EC 2027 Mrs. Cherie Ruiz Vol #: 160
EC 2028 Ms. Michelle Koterba Vol #: 160
EC 2029 Ms. Teresa McGlashan Vol #: 160
EC 2030 Ms. Raquel Richardson Vol #: 160
EC 2031 Ms. Kara Skelly Vol #: 160
EC 2032 Mrs. Joan McMillen Vol #: 160
EC 2033 Ms. Shaunell Brandt Vol #: 160
EC 2034 Ms. Cynthia Lay Vol #: 160
EC 2035 Ms. Nancy Nino Vol #: 160
EC 2036 Ms. Connie Poole Vol #: 160
EC 2037 Miss. Carla Haim Vol #: 160
EC 2038 Mrs. nancy payne Vol #: 160
EC 2039 Mrs. Diane Schaffner Vol #: 160
EC 2040 Mrs. D. E-Platt Vol #: 160
EC 2041 Ms. karen dorfman Vol #: 160
EC 2042 Mrs. Tara Hutchinson Vol #: 160
EC 2043 Mrs. Maria Vickery Vol #: 160
EC 2044 Mrs. S Schultz Vol #: 160
EC 2045 Ms. Joy Om Vol #: 160
EC 2046 Parent and concerned citizen Vol #: 160
EC 2047 Ms. DeAnn Swanson Vol #: 160
EC 2048 Ms. Raechel Lee Reyes Vol #: 160
EC 2049 Mrs. Theresa Lattus Vol #: 160
EC 2050 Mrs. Marcelle Ewing Vol #: 160
EC 2051 Mrs. Nicole Killion, RN Vol #: 160
EC 2052 Ms. Therese Price Vol #: 160
EC 2053 Ms. Juliette Sullivan Vol #: 160
EC 2054 Mrs. Jayne Colton Vol #: 160
EC 2055 Mr. Johan de Besche Vol #: 160
EC 2056 Dr. Debra Mee Vol #: 160
EC 2057 Ms. coleen hulse Vol #: 160
EC 2058 Mr. matthew carpenter Vol #: 160
EC 2059 Ms. Christine Egan Vol #: 160
EC 2060 Ms. Amanda Murphy Vol #: 160
EC 2061 Mrs. Cindy Larson Vol #: 160
EC 2062 Ms. Michaelene Pederson Vol #: 160
EC 2063 Mrs. Deborah Plaver Vol #: 160
EC 2064 Mrs. Margi Briggs Vol #: 160
EC 2065 Mrs. Kelly Yorkey Vol #: 160
EC 2066 Ms. Lynne Swanson Vol #: 160
EC 2067 Mrs. Elizabeth Cien Vol #: 160
EC 2068 Ms. Babette Novak Vol #: 160
EC 2069 Ms. Merry K Bronk Vol #: 160
EC 2070 Mrs. Kathleen Kittrick Vol #: 160
EC 2071 Mrs. Ellen Kovalsky Vol #: 160
EC 2072 Ms. Rajae Nami Vol #: 160
EC 2073 Ms. Monica Granfield Vol #: 160
EC 2074 Mrs. Caron Osberg Vol #: 160
EC 2075 Mrs. LaVonna Connelly Vol #: 160
EC 2076 Mr. Martin Golembiewski Vol #: 160
EC 2077 Mr. Clifford Sullivan Vol #: 160
EC 2078 Ms. Amanda Short Vol #: 160
EC 2079 Mrs. Kristine Heintz Vol #: 160
EC 2080 Ms. gayle materna Vol #: 160
EC 2081 Mrs. Suzanne Thompson Vol #: 160
EC 2082 Mrs. Raine Cherry Vol #: 160
EC 2083 Mrs. Kelly Foglia Vol #: 160
EC 2084 Ms. Grace Smith Vol #: 160
EC 2085 Mrs. Allison Ryan Vol #: 160
EC 2086 Magee-Womens Hospital of UPMC Vol #: 160
EC 2087 Miss. Julie Arts Vol #: 160
EC 2088 Ms. Kris Hammar Vol #: 160
EC 2089 Ms. Kathryn Smith Vol #: 160
EC 2090 individual Vol #: 160
EC 2091 Environmental Work Group Vol #: 160
EC 2092 Mrs. Leslie Pirtle Vol #: 160
EC 2093 Mrs. vicky timm Vol #: 160
EC 2094 Ms. Jenny Port Vol #: 160
EC 2095 Ms. Jessica Dexter Vol #: 160
EC 2096 Ms. Lauren Mullins Vol #: 160
EC 2097 n/a Vol #: 160
EC 2098 Dr. Barton Kunstler Vol #: 160
EC 2099 Mrs. gloria escobar Vol #: 160
EC 2100 Mrs. Ligia Muntean Vol #: 160
EC 2101 Miss. Wendy Taylor Vol #: 160
EC 2102 Ms. Kendel Fesenmyer Vol #: 160
EC 2103 Mrs. Kathleen Evans Vol #: 160
EC 2104 Ms. pamela sousa Vol #: 160
EC 2105 Ms. Sabrina Strawn Vol #: 160
EC 2106 Mrs. Griselda Dupuy Vol #: 160
EC 2107 Ms. Susana Monteverde Vol #: 160
EC 2108 Mrs. A. Lenhart Vol #: 160
EC 2109 Mrs. Stefanie Stricker Vol #: 160
EC 2110 Miss. Manon Legault Vol #: 160
EC 2111 Mrs. Erica Clowers Vol #: 160
EC 2112 Mr. Georgy Vladimirov Vol #: 160
EC 2113 Mrs. Kimberly Heard Vol #: 160
EC 2114 Ms. Joanna Fulginiti Vol #: 160
EC 2115 Mrs. Angela Watters Vol #: 160
EC 2116 Ms. Cheryl Chase Vol #: 160
EC 2117 Mrs. Marianne Gilles Vol #: 160
EC 2118 Ms. rosemarie kauper Vol #: 160
EC 2119 Ms. Cathy Schoenberg Vol #: 160
EC 2120 Mrs. Shannon Spann Vol #: 160
EC 2121 Mrs. Tracy Hirsch Vol #: 160
EC 2122 Ms. Jane Burch-Pesses Vol #: 160
EC 2123 Ms. Erica Yee Vol #: 160
EC 2124 Mrs. Rachel Roy Vol #: 160
EC 2125 Mrs. kelley foster Vol #: 160
EC 2126 Ms. Lisa Robbins Vol #: 160
EC 2127 Mrs. Gretchen Watters Vol #: 160
EC 2128 Mrs. Janette Canare Vol #: 160
EC 2129 Ms. Aniki Steensen Vol #: 160
EC 2130 Mrs. Marian Callahan Vol #: 160
EC 2131 Mrs. Denise Sheriff Vol #: 160
EC 2132 Miss. Kim White Vol #: 160
EC 2133 Ms. Teri Manley-Cozzie Vol #: 160
EC 2134 Mrs. Kimberly Fitzgerald Vol #: 160
EC 2135 Ms. Madalyn Redini Vol #: 160
EC 2136 Mrs. MeYoung Tumis Vol #: 160
EC 2137 Ms. Josi Jenneskens Vol #: 160
EC 2138 Miss. Valerie Gorchinski Vol #: 160
EC 2139 Ms. AM Macauley Vol #: 160
EC 2140 Mr. Chris Crews Vol #: 160
EC 2141 Mrs. Pamela Watters Vol #: 160
EC 2142 Ms. Shideh hojat Vol #: 160
EC 2143 Ms. Sandra Hamlett Vol #: 160
EC 2144 Mrs. Angela Katsavavakis Vol #: 160
EC 2145 Ms. Nancy Degnan Vol #: 160
EC 2146 Ms. deborah salz Vol #: 160
EC 2147 Ms. Bhuvana Murali Vol #: 160
EC 2148 Ms. Kerry Wilson Vol #: 160
EC 2149 Ms. Madeline Smith Vol #: 160
EC 2150 Ms. Desiree Namery Vol #: 160
EC 2151 Ms. Sandy Tate Vol #: 160
EC 2152 Mr. Terry McGinty Vol #: 160
EC 2153 Ms. SandraElizabeth Gresham Vol #: 160
EC 2154 Ms. April Lynskey Vol #: 160
EC 2155 Mrs. Karen Johnson Vol #: 160
EC 2156 Miss. Staci Thompson Vol #: 160
EC 2157 Mrs. Lynn Leitch Vol #: 160
EC 2158 Ms. Jaime Boswell Vol #: 160
EC 2159 Ms. Cindy Rose Vol #: 160
EC 2160 Mrs. Kelly Blum Vol #: 160
EC 2161 Mrs. Molly Mac Ban Vol #: 160
EC 2162 Senior Services Vol #: 160
EC 2163 Miss. Phyllis Marino Vol #: 160
1998D-0077 Treatment of osteoarthritis/drugs, devices and biological pt
LET 1 Osteoarthritis Reseach Society International (OARS Vol #: 1
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
C 21 Washington Legal Foundation Vol #: 3
C 22 American Society for Clinical Pathology Vol #: 3
2006N-0067 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
LET 1 FDA/CVM Vol #: 1
2006N-0420 Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
NAL 1 FDA Vol #: 1
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 1813 D Peil Vol #: 18
C 1814 J Link Vol #: 18
C 1815 B Bouts Vol #: 18
C 1816 L Price Vol #: 18
C 1817 P Adams Vol #: 18
C 1818 V Roten Vol #: 18
C 1819 D Marten Vol #: 18
C 1820 C Griffin Vol #: 18
C 1821 J Chapa Vol #: 18
C 1822 E Knudsvig Vol #: 18
C 1823 V Romano Vol #: 18
C 1824 P Woznik Vol #: 18
C 1825 D Prentiss Vol #: 18
C 1826 R Williams Vol #: 18
C 1827 H Pickens Vol #: 18
C 1828 P Henschen Vol #: 18
C 1829 D Story Vol #: 18
C 1830 M Gauthier Vol #: 18
C 1831 J Passenheim Vol #: 18
C 1832 C Reeves Vol #: 18
C 1833 E Gordon Vol #: 18
C 1834 B Turner Vol #: 18
C 1835 H Schmitt Vol #: 18
C 1836 E Krall Vol #: 18
C 1837 C Klucken Vol #: 18
C 1838 D Cronauer Vol #: 18
C 1839 P Bain Vol #: 18
C 1840 M Purdy Vol #: 18
C 1841 K Fry Vol #: 18
C 1842 D Lamberson Vol #: 19
C 1843 W. Engel Vol #: 19
C 1844 B Thompson Vol #: 19
C 1845 S Schaaf Vol #: 19
C 1846 P Palmer Vol #: 19
C 1847 F Beuf Vol #: 19
C 1848 E Mandell Vol #: 19
C 1849 R Schlossman Vol #: 19
C 1850 F Keifer Vol #: 19
C 1851 Caroline Allergy & Asthma Consultants Vol #: 19
C 1852 R Odom Vol #: 19
C 1853 A Little Vol #: 19
C 1854 C Bauer Vol #: 19
C 1855 A Koltis Vol #: 19
C 1856 C Weber Vol #: 19
C 1857 R Skender Vol #: 19
C 1858 S Franks Vol #: 19
C 1859 L Roszelt Vol #: 19
C 1860 B Woodham Vol #: 19
C 1861 B. Hickman Vol #: 19
C 1862 I Achterberg Vol #: 19
C 1863 J Hlavac Vol #: 19
C 1864 S Germond Vol #: 19
C 1865 B Studer Vol #: 19
C 1866 M Pillath Vol #: 19
C 1867 G Burkhardt Vol #: 19
C 1868 C Smith Vol #: 19
ELET 1 Lisa Delaney Vol #: 19
2006P-0307 To amend 21CFR 201.17 regarding expiration dates
LET 4 Sapna Lohiya 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"
C 2 David Hogg Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 139 Samuel L. D. Vol #: 7
C 140 Karen Reyes Vol #: 7
2006P-0496 Determine whether Sulfamethoxazole, Trimethoprim, and Phenazopyride HCI, have been voluntarily withdrawn or withheld for safety or efficacy reasons
AMD 1 Vintage Pharmaceuticals, LLC Vol #: 1
2006P-0505 ANDA for Ursodial Capsules USP, 100 mg 200 mg, and 400 mg
PAV 1 Gary J. Buehler Vol #: 1
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
C 7 M. Hartsook Vol #: 1
NCR 1 FDA Vol #: 1
NCR 2 Number not Used Vol #: 1
2007D-0213 Guidance for Industry on Providing Regulatory Submissions in Electronic Format Receipt Date
C 4 TEVA PHARMACEUTICALS USA Vol #: 1
2007D-0310 Companion to Guidance for Industry on Pharmacogenomic Data
GDL 1 Guidance Vol #: 1
NAD 1 FDA Vol #: 1
NAL 1 FDA Vol #: 1
SS 1 Number not Used Vol #: 1

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