Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on May 13, 2002

TABLE OF CONTENTS

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[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
94S-0120 510K Substantially Equivalent List *
98N-0583 Exports: Notification and Recordkeeping requirements *
98P-1121 Grated Parmesan Cheese Deviating from Identity standard *
99D-5347 Transmission of Zoonoses By Blood and Blood Products *
00N-1526 Proposal to Debar Robert A. Fiddes,M.D.;Notice of Oppportuni *
00N-1527 Proposal to Debar Laverne M. Charpentier;Notice of Opportuni *
00N-1528 Proposal to Debar Delfina Hernandez;Notice of Opportunity *
00N-1529 Proposal to Debar Elaine Yee-Ling Lai:Notice of Opportunity *
01D-0577 Class II Special Controls Guidance Cutaneous Carbon Dioxide *
01P-0495 Determine Ultram's safety or effectiveness reasons *
02P-0191 Request for immediate final approval of tramadol Hydrochlori *

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

MT 4 HFD-560 & International Testing Corporat Vol#: 60

82P-0371 Warning labels on cans soldered with lead

BKG 1 Background Material Vol#: 1

91N-0165 Lead-soldered food cans

BKG 1 Background Material Vol#: 1

94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8580 Marjorie Hill Vol#: 116

94S-0120 510K Substantially Equivalent List

LST 114 List of April 2002 Vol#: 27

95N-0253 Sale & Distribution Cigarettes protect children/adolescents

CA 1899 Stiver Wheeler Vol#: 5006

CA 1900 Micheal Fulton Vol#: 5006

CA 1901 Gretchen Schrader Vol#: 5006

CA 1902 Dee Olson, R. R. T. Vol#: 5006

CA 1903 W. Dan Joslyn Vol#: 5006

CA 1904 Darryl Hyatt Vol#: 5006

CA 1905 Avis Austin Vol#: 5006

CA 1906 Joanne Jo Durocher Vol#: 5006

CA 1907 Meg C. Nadig Vol#: 5006

CA 1908 Sue Tano Vol#: 5006

CA 1909 Jean Hinton Vol#: 5006

CA 1910 Linda M. Schwartz Vol#: 5006

CA 1911 Gail Manso Vol#: 5006

CA 1912 Lynn Fireside Vol#: 5006

CA 1913 Diana Hall Vol#: 5006

CA 1914 Jane E. Singer Vol#: 5006

CA 1915 Helen Steinmetz Vol#: 5006

CA 1916 Donna McNamara Vol#: 5006

CA 1917 Claire McCleery Vol#: 5006

CA 1918 Moreen Joslyn Vol#: 5006

CA 1919 Kristy Browder Vol#: 5006

CA 1920 Meghan O'Shea Vol#: 5006

CA 1921 Pam Ashman Vol#: 5006

CA 1922 E. Jimmie Loder Vol#: 5006

CA 1923 Kristin Kinney Vol#: 5006

CA 1924 Terri Warren, R. R. T. Vol#: 5006

CA 1925 Charli Brown Vol#: 5006

CA 1926 Yvonne P. Browne Vol#: 5006

CA 1927 Jerry M. Harris Vol#: 5006

CA 1928 Karen Brodsky Vol#: 5006

CA 1929 Sandra Greenleaf Vol#: 5006

CA 1930 Leslie K. Sheinar Vol#: 5006

CA 1931 Richard Deschenes Vol#: 5006

CA 1932 Karen Hale Vol#: 5006

CA 1933 S. K. Johnston Vol#: 5006

CA 1934 Gail Locke Vol#: 5006

CA 1935 Jane Kimball Vol#: 5006

CA 1936 Erin Minks, D. O. Vol#: 5006

CA 1937 Lynn DuPratt Vol#: 5006

CA 1938 John & Donna M. Gaddis Vol#: 5006

CA 1939 Laurie A. McDonald Vol#: 5006

CA 1940 Patricia Ashley Vol#: 5006

CA 1941 Jerome E. McCleary Vol#: 5006

CA 1942 Joye H. Casey Vol#: 5006

CA 1943 Linda M. Wiley Vol#: 5006

CA 1944 Jeanette Saffien Vol#: 5006

CA 1945 Barbara Levy Vol#: 5006

CA 1946 Karol Dahlen Vol#: 5006

CA 1947 Edward C. Guinleaf Vol#: 5006

CA 1948 Karen Hale Vol#: 5006

CA 1949 Sue A. Joslyn, Ph. D. Vol#: 5006

CA 1950 Sandon Saffier Vol#: 5006

CA 1951 M. P. Hamill-Larson, R. N., R. S. N. Vol#: 5006

CA 1952 Erin A. Lincoln Vol#: 5006

CA 1953 Andrew Walker, III Vol#: 5006

CA 1954 Patricia Sheabolk Vol#: 5006

CA 1955 Illegible Vol#: 5006

CA 1956 Maggie Selenski, R. N. Vol#: 5006

CA 1957 Larson Divine-Leal Vol#: 5006

CA 1958 Hilary Matthewson Vol#: 5006

CA 1959 April Durbin Vol#: 5006

CA 1960 Emily Jackson Vol#: 5006

CA 1961 Natalie Jones Vol#: 5006

CA 1962 Kristen Shroger Vol#: 5006

CA 1963 Lynn Busby Vol#: 5006

CA 1964 Christie Carmen Vol#: 5006

CA 1965 Derrick Adams Vol#: 5006

CA 1966 Peter Kasarsleis Vol#: 5006

CA 1967 David P. Shahan Vol#: 5006

CA 1968 Brookeyre Adkins Vol#: 5006

CA 1969 Colin Sands Vol#: 5006

CA 1970 Melissa Spencer Vol#: 5006

CA 1971 Julie Sebasten Vol#: 5006

CA 1972 Tara Pacella Vol#: 5006

CA 1973 Private Parts Vol#: 5006

CA 1974 Angel Campbell Vol#: 5006

CA 1975 Abby Ross Vol#: 5006

CA 1976 Ashley Morris Vol#: 5006

CA 1977 Michelle Merritt Vol#: 5006

CA 1978 Virginia Gron Vol#: 5006

CA 1979 Todd Warrick Vol#: 5006

CA 1980 Maureen Crum Vol#: 5006

CA 1981 Clarice Bramley Vol#: 5006

CA 1982 Lynn Sowards Vol#: 5006

CA 1983 Aimee Villavicencio Vol#: 5006

CA 1984 David Waespe Vol#: 5006

CA 1985 Claudia Davenport Vol#: 5006

CA 1986 Nick McClure Vol#: 5006

CA 1987 David Hopkins Vol#: 5006

CA 1988 Elisabeth M. Vol#: 5006

CA 1989 Jaime Allen Vol#: 5006

CA 1990 Brooke Buehler Vol#: 5006

CA 1991 Corey Dunn Vol#: 5006

CA 1992 Tiffany Coplon Vol#: 5006

CA 1993 Stacy Holman Vol#: 5006

CA 1994 Amber Mortensen Vol#: 5006

CA 1995 Carlin Wainscott Vol#: 5006

CA 1996 Shelley Taylor Vol#: 5006

CA 1997 Lindsay Glisson Vol#: 5006

CA 1998 Rachael Schneiders Vol#: 5006

CA 1999 Derek Melvin Vol#: 5007

CA 2000 Adonika Vasilauskas Vol#: 5007

CA 2001 Holly Hestand Vol#: 5007

CA 2002 Nola Smith Vol#: 5007

CA 2003 Crystal Garrett Vol#: 5007

CA 2004 Scott Aehrenbach Vol#: 5007

CA 2005 Scott Fearman Vol#: 5007

CA 2006 Eleanor Chung Vol#: 5007

CA 2007 Shane Roberts Vol#: 5007

CA 2008 Carolyn Heller Vol#: 5007

CA 2009 Megan Adkins Vol#: 5007

CA 2010 Ben McWhorter Vol#: 5007

CA 2011 Shelly Gentry Vol#: 5007

CA 2012 Chris Kenney Vol#: 5007

CA 2013 Amy Oldham Vol#: 5007

CA 2014 Nicole Jackson Vol#: 5007

CA 2015 Taylor Schultz Vol#: 5007

CA 2016 Jeff Bradford Vol#: 5007

CA 2017 John Rodwall Vol#: 5007

CA 2018 Marcus Biggham Vol#: 5007

CA 2019 Lee E. Henderson Vol#: 5007

CA 2020 Chris Hyms Vol#: 5007

CA 2021 Shelly Petty Vol#: 5007

CA 2022 Sean Orlando Vol#: 5007

CA 2023 James Stall Vol#: 5007

CA 2024 Amy Scanlon Vol#: 5007

CA 2025 Ray Frederich Vol#: 5007

CA 2026 Skip McCoy Vol#: 5007

CA 2027 Matthew DeMoss Vol#: 5007

CA 2028 Megan Pettibone Vol#: 5007

CA 2029 Ash Smith Vol#: 5007

CA 2030 Julia Wooden Vol#: 5007

CA 2031 Shannon Cook Vol#: 5007

CA 2032 Micheal Hughes Vol#: 5007

CA 2033 Josh Faio Vol#: 5007

CA 2034 Jessica Narramore Vol#: 5007

CA 2035 Katherine Smith Vol#: 5007

CA 2036 Kellie Geranflo Vol#: 5007

CA 2037 Jess Muetterties Vol#: 5007

CA 2038 Erin Orthmeyer Vol#: 5007

CA 2039 J. J. Insnir Vol#: 5007

CA 2040 Ed Page Vol#: 5007

CA 2041 Chris Brown Vol#: 5007

CA 2042 Krystal Toland Vol#: 5007

CA 2043 Nietzan Ortega Vol#: 5007

CA 2044 Matt Windlord Vol#: 5007

CA 2045 George McNeil Vol#: 5007

CA 2046 Hoang Tran Vol#: 5007

CA 2047 Margues Fincher Vol#: 5007

CA 2048 Jill Wassell Vol#: 5007

CA 2049 Ahmed El-Aref Vol#: 5007

CA 2050 Greg Gibson Vol#: 5007

CA 2051 Dan Huffman Vol#: 5007

CA 2052 Jaime Cougle Vol#: 5007

CA 2053 Michele Helty Vol#: 5007

CA 2054 Christin Adarr Vol#: 5007

CA 2055 Meagon Ligons Vol#: 5007

CA 2056 Jennifer McDowell Vol#: 5007

CA 2057 Katie Tyra Vol#: 5007

CA 2058 Jackie Reyenga Vol#: 5007

CA 2059 Kathy Yoon Vol#: 5007

CA 2060 Diana D'Amato Vol#: 5007

CA 2061 Ryan Graves Vol#: 5007

CA 2062 Voment Faggish Vol#: 5007

CA 2063 Peter Wall Vol#: 5007

CA 2064 Chanee' Gaskin Vol#: 5007

CA 2065 Joey Fienup Vol#: 5007

CA 2066 Leah Beebe Vol#: 5007

CA 2067 Billy Holloway Vol#: 5007

CA 2068 Jennifer Orlick Vol#: 5007

CA 2069 Michelle Absalordon Vol#: 5007

CA 2070 Bryan A. Road Vol#: 5007

CA 2071 Bunni Rotenberry Vol#: 5007

CA 2072 Kristina Knobel Vol#: 5007

CA 2073 J. J. Insnir Vol#: 5007

CA 2074 Philip Jackson Vol#: 5007

CA 2075 Shikina Olds Vol#: 5007

CA 2076 Micheal Lupher Vol#: 5007

CA 2077 Matt Keenett Vol#: 5007

CA 2078 Steven King Vol#: 5007

CA 2079 Natasha Sheh Vol#: 5007

CA 2080 Anthony Brown Vol#: 5007

CA 2081 Derek Turner Vol#: 5007

CA 2082 Cynthia Hollingsworth Vol#: 5007

CA 2083 Ricky Evans Vol#: 5007

CA 2084 Ceranty A. Poole Vol#: 5007

CA 2085 Megan Ziegert Vol#: 5007

CA 2086 Emily Barr Vol#: 5007

CA 2087 Douglas Lee Vol#: 5007

CA 2088 Laura Looney Vol#: 5007

CA 2089 Stacey Jones Vol#: 5007

CA 2090 Biarra Taroselli Vol#: 5007

CA 2091 Jyoti Bhatia Vol#: 5007

CA 2092 Audrey Lempkin Vol#: 5007

CA 2093 Micheal Enoch Vol#: 5007

CA 2094 Chris Weaver Vol#: 5007

CA 2095 Becky Mayer Vol#: 5007

CA 2096 Jesse Scott Vol#: 5007

CA 2097 Charles Stompaugh Vol#: 5007

CA 2098 Ashlee Thorson Vol#: 5007

98N-0583 Exports: Notification and Recordkeeping requirements

LET 2 HF-11 to Sandler, Travis & Rosenbeg, P.A Vol#: 2

LET 3 HF-11 to Consumer Healthcare Prods Assn Vol#: 2

LET 4 HF-11 to CTFA Vol#: 2

98N-1038 Irradiation in the production, processing, &handling of food

EMC 1036 Debbie Dunbar Ortman Vol#: 197

98P-1121 Grated Parmesan Cheese Deviating from Identity standard

ANS 5 HFS-800 to Sartori Food Corporation Vol#: 1

LET 7 Sartori Food Corporation Vol#: 1

99D-5347 Transmission of Zoonoses By Blood and Blood Products

C 32 American Assn of Blood Banks (AABB) Vol#: 8

C 33 American Red Cross Vol#: 8

99P-1340 Declared Eternity eau de Parfum Misbranded

EMC 370 Eric J. White Vol#: 21

EMC 371 Karin Kelly-Givens Vol#: 21

EMC 372 Ottavia P. Chiaradonna Vol#: 21

EMC 373 Priscilla Farrell Vol#: 21

EMC 374 Brenda McCree Vol#: 21

99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O

EC 1 Ms. Lynda Hayes Vol#: 1

EMC 1 Claire Flint Vol#: 1

EMC 2 Dr. Daniel H. Duffy Sr. Vol#: 1

EMC 3 Donna Burkett Vol#: 1

EMC 4 Steve Nazigian Vol#: 1

EMC 5 Mark Strong Vol#: 1

EMC 6 Gail Barmoy Vol#: 1

EMC 7 Emily Ladow Vol#: 1

EMC 8 Mike Anderson Vol#: 1

EMC 9 Robert Cohen Vol#: 1

EMC 10 Carol Hartwell Vol#: 1

EMC 11 Christine Blackard Vol#: 1

EMC 12 Cheryl Christensen Vol#: 1

EMC 13 Linda Piel Vol#: 1

EMC 14 James Grayson McNeil Vol#: 1

EMC 15 Bina Robinson Vol#: 1

EMC 16 K. Rasmussen Vol#: 1

EMC 17 April Walker Vol#: 1

EMC 18 Gordon W. Watts Vol#: 1

EMC 19 Serafina Minerva Vol#: 1

EMC 20 Andrea Ross Vol#: 1

EMC 21 Julie Shemko Vol#: 1

EMC 22 Kim Ganzer Vol#: 1

EMC 23 Roger Brenneise Vol#: 1

EMC 24 William J. Boerst Vol#: 1

EMC 25 Pam Gaskell Vol#: 1

EMC 26 Madelene Furtado Vol#: 1

EMC 27 Melanie Wilkinson Vol#: 1

EMC 28 Beth Sopko Vol#: 1

EMC 29 Beth Sopko Vol#: 1

EMC 30 No signature Vol#: 1

EMC 31 Michele Hayes Vol#: 1

EMC 32 no signature Vol#: 1

EMC 33 Emily A. Beighley Vol#: 1

EMC 34 Diann Messer Vol#: 1

EMC 35 Fran Snyder Vol#: 1

EMC 36 Catherine Knollmeyer Vol#: 1

EMC 37 David Voremberg Vol#: 1

EMC 38 Nancy Moulton Vol#: 1

EMC 39 Ellen R. Holley Vol#: 1

00N-1526 Proposal to Debar Robert A. Fiddes,M.D.;Notice of Oppportuni

LET 1 HFD-1 Vol#: 1

00N-1527 Proposal to Debar Laverne M. Charpentier;Notice of Opportuni

LET 1 HFD-1 Vol#: 1

00N-1528 Proposal to Debar Delfina Hernandez;Notice of Opportunity

LET 1 HFD-1 Vol#: 1

00N-1529 Proposal to Debar Elaine Yee-Ling Lai:Notice of Opportunity

LET 1 HFD-1 Vol#: 1

00P-1322 Food Labeling and Allergen Contamination Control

C 502 Faye Macbeth Vol#: 29

C 503 Shirley G. Whitley Vol#: 29

01D-0577 Class II Special Controls Guidance Cutaneous Carbon Dioxide

C 2 Radiometer Medical A/S Vol#: 1

01N-0067 Reclassification of Dental Mercury

C 2 The Honorable Mark E. Udall (CI) Vol#: 1

01N-0339 Medical Washer & Medical Washer-Disinfector

EC 4 Consumer Vol#: 1

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

CH 42 Marilyn Evenson Vol#: 7

01P-0495 Determine Ultram's safety or effectiveness reasons

C 6 Apotex Corp. Vol#: 2

02M-0217 Medtronic Activa Parkinson's Control Therapy, P960009/s0007

AAV 1 Medtronid Neurological Vol#: 1

02M-0218 PMA QuantiFERON-tb, P010033

AAV 1 Cellestis Limited Vol#: 1

02P-0191 Request for immediate final approval of tramadol Hydrochlori

C 1 Teva Inc. Vol#: 1

02V-0157 laser light show

ACK 1 HFA-305 to The Ultimate Place 2B Vol#: 1

02V-0221 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Choctaw Resort Development Enterprise Vol#: 1

02V-0222

ACK 1 HFA-305 Vol#: 1

VAR 1 Laser Energy Vol#: 1