DOCKETS ENTERED on 04/11/01

Docket Title

Number

Documents received by the Dockets Management Branch "MAY" be posted on the internet. PLEASE DO NOT INCLUDE personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

THE DOCUMENTS IN THE FOLLOWING DOCKETS WILL BE LINKED AS SOON AS POSSIBLE. CLICK ON THE (*) TO SEE THE CONTENTS OF THE LISTED DOCKET. SOME DOCKETS, NOT LINKED TO THIS TABLE OF CONTENTS, WILL BE LINKED ELSEWHERE ON THE DOCKETS PAGE

80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use *

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec *

97D-0302 Consumer-Directed Broadcast Advertisements *

97P-0329 Require Quantitative Labeling of Caffeine Content *

00A-0355 Industrial Marking Equipment Regarding Food Packing *

00D-1393 Screening tests labeled for use w/ Cadaveric blood Specimens *

00D-1598 Voluntary Labeling for Bioengineered Foods *

00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals *

00D-1681 Potassium Iodide as a Thyroid Blocking Agent *

00N-1625 Rescission of Substantially Equivalent Decisions & Rescissio *

00N-1634 Public Hearing Before a Public Advisory Committee *

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *

00P-1472 Over-the-counter sodium phosphate bowel preparation products *

00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices *

00P-1578 Safety of Med.Devices Mfg. with Silicone Catalyzed w/ Hexach *

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *

01P-0148 Misbranding of reprocessed single use medical devices *

80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use

RC 1 Oakhurst Co. Vol#: 8

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec

LET 3 CFSAN Vol#: 16

97D-0302 Consumer-Directed Broadcast Advertisements

EMC 1 Richard Rhodes Vol#: 1

97P-0329 Require Quantitative Labeling of Caffeine Content

C 241 Shawnee Community Mental Health Center Vol#: 4

98V-0377 Laser Light Show, Mobolazer 10-200, ML10-300, ML10-300W

VRA 2 HFZ-340 to Tim Edwards Marketing Vol#: 1

98V-1229 Mobolazer ML10-200,ML10-300,ML10-300W, ML10-1000

VRA 2 HFZ-340 to Buckmaster Productions Vol#: 1

99D-2248 Efficacy of Anthelmintics for Bovines,Ovines and Caprines

GDL 2 GUIDANCE Vol#: 1

GDL 3 GUIDANCE Vol#: 1

GDL 4 GUIDANCE Vol#: 1

GDL 5 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

99V-0184 Variance Laser Light Show Projector Model #LP1

VRA 3 HFZ-340 to John's Laser Productions Vol#: 1

99V-0190 Variance Laser Light Show LSD110XL MRAK10 & MRAK250

VRA 2 HFZ-340 to Artistic Laser Productions Vol#: 1

00A-0355 Industrial Marking Equipment Regarding Food Packing

MT 1 HFS-215 to Cinzia Schlicksup Vol#: 1

00D-1393 Screening tests labeled for use w/ Cadaveric blood Specimens

C 6 CORE, Ctr. for Organ Recovery & Educatio Vol#: 1

00D-1598 Voluntary Labeling for Bioengineered Foods

C 947 Patricia Martin Vol#: 85

C 948 Mike Guarino Vol#: 85

C 949 Joan Green Vol#: 85

C 950 Michele Lippert Vol#: 85

C 951 Renee G. Weinberg & Lewis Weingberg Vol#: 85

C 952 Frank M. Posey Vol#: 85

C 953 Mel & Gail Minthorn Vol#: 85

C 954 Sue Doell Vol#: 85

C 955 Ann M. Mullen Vol#: 86

C 956 Luann Hickey Vol#: 86

C 957 Brittany Cox Vol#: 86

C 958 The Mississippi 2020 Network Vol#: 86

C 959 Marisa Longo Vol#: 86

C 960 Rosalyn Esposito Vol#: 86

C 961 Renate Frey Vol#: 86

C 962 Marian McKenzie Vol#: 86

C 963 Judith C. Shalay, MD Vol#: 86

C 964 Amy Hess Vol#: 86

C 965 Lesli Wingate Vol#: 86

C 966 Carol Browner Vol#: 86

C 967 Beth Weber-Guarino Vol#: 86

C 968 Suzette L. Binder Vol#: 86

C 969 Rebecca Stockert Vol#: 86

C 970 Kim Dook Vol#: 86

C 971 Darnell Forthe Vol#: 86

C 972 Jordanna Thigpen Vol#: 86

C 973 Deborah Walsh Vol#: 86

C 974 Marc Pilisuk Vol#: 86

C 975 Grover Stock Vol#: 86

C 976 Larry & Gimone Hall Vol#: 86

C 977 Thomas W. Patterson Vol#: 86

C 978 Andrea Kiepe Vol#: 86

C 979 Diana Oleskevich Vol#: 86

C 980 Tracey A. Cook Vol#: 86

C 981 Patricia J. Alvarez Vol#: 86

C 982 Alexandria C. Fisher Vol#: 86

C 983 V. Lynch Vol#: 86

C 984 Jennifer Lee Vol#: 86

C 985 Cynthia K. Faust Vol#: 86

C 986 Shirley Hitzer Vol#: 86

C 987 Carol Hayman Vol#: 24

C 988 Jennifer Miner Vol#: 86

C 989 Shannon Fernandez Vol#: 86

C 990 Beth Treweek Vol#: 86

C 991 Shawna Owen Vol#: 86

C 992 Christian Bergeron Vol#: 87

C 993 Daniel Parker Vol#: 87

C 994 Cate Campbell Vol#: 87

C 995 Joni Gilton Vol#: 87

C 996 Rick Katterman Vol#: 87

C 997 Dorothy Fromer Vol#: 87

C 998 Converse B. Cone Vol#: 87

C 999 Jean Dakern Vol#: 87

C 1000 Paul P. Loduha Vol#: 87

C 1001 Jay T. Stratton Vol#: 87

C 1002 Ms. Amelia L. Hammer Vol#: 87

C 1003 Aline Manzi Vol#: 87

C 1004 Gary Huggens Vol#: 87

C 1005 Marion C. Honors, CSJ Vol#: 87

C 1006 John F. Fay Vol#: 87

C 1007 R. Benic Vol#: 87

C 1008 Joanne G. Weber Vol#: 87

C 1009 Donald F. Kostur Vol#: 87

C 1010 Brian Skeele Vol#: 87

C 1011 Dorothy Olinger Vol#: 87

C 1012 Dave Kraft Vol#: 87

C 1013 Sherwood Barton Bromley Vol#: 87

C 1014 Estelle Jacobs Vol#: 87

C 1015 Stephanie J. Weigel, PhD Vol#: 87

C 1016 Wanda Harvey-Lewis Vol#: 87

C 1017 Georgia Phells Vol#: 87

EMC 1993 Mary C. McGuinness Vol#: 85

EMC 1994 Karen Lucka-Beristain Vol#: 85

EMC 1995 Pamela Malone Vol#: 85

EMC 1996 William Clisso Vol#: 85

EMC 1997 Lorraine Rheault Vol#: 85

EMC 1998 Sister Annette M. Sinagra Vol#: 85

EMC 1999 Lorraine Rheault Vol#: 85

EMC 2000 Aurora Dawn-Rose Vol#: 85

EMC 2001 Deb Poole Vol#: 85

EMC 2002 Henry Stilmack Vol#: 85

EMC 2003 Dan Broadhead Vol#: 85

EMC 2004 Rogene K. Brick Vol#: 85

EMC 2005 Betsy Green Vol#: 85

EMC 2006 Kevin Moran Vol#: 85

EMC 2007 David & Julia Garcia Vol#: 85

EMC 2008 Jody Sandhaus Vol#: 85

EMC 2009 Anthony Caplan Vol#: 85

EMC 2010 Lori Barklage Vol#: 85

EMC 2011 Blanche Nemeth Vol#: 85

EMC 2012 Sarah Ferraro Vol#: 85

EMC 2013 Evalee Jackson Vol#: 85

EMC 2014 Donald Martin White Vol#: 85

EMC 2015 Gail Boaz Vol#: 85

EMC 2016 Gail Boaz Vol#: 85

EMC 2017 Vincent Penoro Vol#: 85

EMC 2018 Vincent Penoro Vol#: 85

EMC 2019 Stephanie Trasoff Vol#: 85

EMC 2020 Lin Glen Vol#: 85

EMC 2021 Lin Glen Vol#: 85

EMC 2022 L. McDonald Vol#: 85

EMC 2023 Sharon Zayac Vol#: 85

EMC 2024 Stephanie Frizzell Vol#: 85

EMC 2025 Russell Frizzell Vol#: 85

EMC 2026 J. Kleinberg Vol#: 85

EMC 2027 Charles Miller Vol#: 85

EMC 2028 Charles Miller Vol#: 85

EMC 2029 John Root Vol#: 85

EMC 2030 Janet Stein Vol#: 85

EMC 2031 Deanna Davis Vol#: 85

EMC 2032 S. Blackwell Vol#: 85

EMC 2033 Jenny Lee Vol#: 85

EMC 2034 Alan Sparrow Vol#: 85

EMC 2035 Shannon Miller Vol#: 85

EMC 2036 Ralph W. Maker Vol#: 85

EMC 2037 Sandra Fulmer Vol#: 85

EMC 2038 Sandra Miller Vol#: 85

EMC 2039 Elise Brown Vol#: 85

EMC 2040 Lynn Ellis Vol#: 85

EMC 2041 Christopher Reed Vol#: 85

EMC 2042 Fran Schutta Vol#: 85

EMC 2043 Rebecca Smith Vol#: 85

EMC 2044 Frances Schutta Vol#: 85

EMC 2045 Frances Schutta Vol#: 85

EMC 2046 Michele Wright Vol#: 85

EMC 2047 Frances Schutta Vol#: 85

EMC 2048 Sherri Nakamoto Vol#: 85

EMC 2049 Jake Nakamoto Vol#: 85

EMC 2050 Rachel Gately Vol#: 85

EMC 2051 Joanne Comito Vol#: 85

EMC 2052 Jeanne Rem Vol#: 85

EMC 2053 Archibald Van Housenhour Vol#: 85

EMC 2054 Walt Oicle Vol#: 85

EMC 2055 Chris Doty Vol#: 85

EMC 2056 Kelly Sachs Vol#: 85

EMC 2057 Georgia Dow Vol#: 85

EMC 2058 Thomas Koutsoukos Vol#: 85

EMC 2059 Julie Wright Vol#: 85

EMC 2060 Davide Wright Vol#: 85

EMC 2061 Susan Heckel Vol#: 85

EMC 2062 Edward K. Hurley, Ed.D Vol#: 85

EMC 2063 Edward K. Hurley, Ed.D Vol#: 85

EMC 2064 Mary Lou Emelander Vol#: 85

EMC 2065 Dylan Charles Vol#: 85

EMC 2066 Ken Fager Vol#: 85

EMC 2067 David Fetler Vol#: 85

EMC 2068 Roger Stolte Vol#: 85

EMC 2069 Peggy Baumler Vol#: 85

EMC 2070 Grady Howell Vol#: 85

EMC 2071 Deb Harrell Vol#: 85

EMC 2072 William Hertling Vol#: 85

EMC 2073 Sunny Walters Vol#: 85

EMC 2074 Ed McDermott Vol#: 85

EMC 2075 Jodie Duplisea Vol#: 85

EMC 2076 Leslie Linnebur Vol#: 85

EMC 2077 Ronald A. Wehrenberg Vol#: 85

EMC 2078 William James Vol#: 85

EMC 2079 Dianne Mogilevsky & Family Vol#: 85

EMC 2080 Larkin Sten Vol#: 85

EMC 2081 Carlos Guadarrama Vol#: 85

EMC 2082 Jeff Smith Vol#: 85

EMC 2083 Nelda Zehner Vol#: 85

EMC 2084 Lance Leonard Vol#: 85

EMC 2085 Jennifer Dutcher Vol#: 85

EMC 2086 Sarah Pearson Vol#: 85

EMC 2087 Norman A. Bing Vol#: 85

EMC 2088 Patrica Nash Vol#: 85

EMC 2089 Grag Butera Vol#: 85

EMC 2090 Nanette Mellgren, RD Vol#: 85

EMC 2091 Erika Jewell Vol#: 85

EMC 2092 Lisa Kobeck Vol#: 85

EMC 2093 Fran Costigan Vol#: 85

EMC 2094 Sheila D. Fox Vol#: 85

EMC 2095 Sunny Walters Vol#: 85

EMC 2096 Viola Wallace Vol#: 85

EMC 2097 Janet Pioccone Vol#: 85

EMC 2098 Katherine Congdon-Caldwell Vol#: 85

EMC 2099 Daniel Baker Vol#: 85

EMC 2100 Carlos A. Gonzalez Vol#: 85

EMC 2101 Stephenie Cowan Vol#: 86

EMC 2102 Patricia Dean Vol#: 86

EMC 2103 Vincent Waters Vol#: 86

EMC 2104 Marc Carlin Vol#: 86

EMC 2105 Jane Kelly Vol#: 86

EMC 2106 Sean Corliss Vol#: 86

EMC 2107 Becky Mansfield Vol#: 86

EMC 2108 Lynelle Lyons Vol#: 86

EMC 2109 JoAnne Rome Vol#: 86

EMC 2110 Zaakia Bailey Vol#: 86

EMC 2111 Leston Faulds Vol#: 86

EMC 2112 Adrian Legg Vol#: 86

EMC 2113 Valerie DeLoach Vol#: 86

EMC 2114 Johnathan Beere Vol#: 86

EMC 2115 Pat Rasmussen Vol#: 86

EMC 2116 Debbie West Vol#: 86

EMC 2117 Beth Ferrara Vol#: 86

EMC 2118 Robin Inman Vol#: 86

EMC 2119 John P. Scahill Vol#: 86

EMC 2120 Barbara Monsolino Vol#: 86

EMC 2121 Richard Stahlhut Vol#: 86

EMC 2122 Stuart Vol#: 86

EMC 2123 Phyllida Paterson, MD Vol#: 8621

EMC 2124 Sean Boyd Vol#: 86

EMC 2125 Tim Gallaher Vol#: 86

EMC 2126 Patrick Mayhew Vol#: 86

EMC 2127 Rossana Baptista Vol#: 86

EMC 2128 Sally Rist Vol#: 86

EMC 2129 The Annie Appleseed Project Vol#: 86

EMC 2130 Robert Horn Vol#: 86

EMC 2131 L. Clapp Vol#: 86

EMC 2132 Dr. Fran Assaf Vol#: 86

EMC 2133 Dorothy Olinger Vol#: 86

EMC 2134 Robin J. Carter, MAJ US Army (Ret) Vol#: 86

00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals

C 6 Cox Associates Vol#: 1

00D-1681 Potassium Iodide as a Thyroid Blocking Agent

C 5 Dept. of Environmental Quality, Michigan Vol#: 1

00N-1625 Rescission of Substantially Equivalent Decisions & Rescissio

C 4 Abbott Laboratories Vol#: 1

00N-1634 Public Hearing Before a Public Advisory Committee

EMC 1 Public Citizen's Health Research Group Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 9790 Ricky Schaffer Vol#: 729

C 9791 Kathleen Houlihan Vol#: 729

C 9792 Melanie Smith Vol#: 729

C 9793 Ruth Dimwitt Vol#: 729

C 9794 James A Coshen Vol#: 729

C 9795 Greg Decker Vol#: 729

C 9796 Elizabeth McConnell Vol#: 729

C 9797 Mrs R B Kemp Vol#: 729

C 9798 Cleo Michelsen Vol#: 729

C 9799 Ellie Pruess Vol#: 729

C 9800 Nancy Kramer Vol#: 729

C 9801 Connie Mae Vol#: 729

C 9802 Ruth W Block Vol#: 729

C 9803 G Paulus Vol#: 729

C 9804 Penny Holland Vol#: 729

C 9805 Karen Daffy Vol#: 729

C 9806 Veronica Cook Vol#: 729

C 9807 Jane Friedman Vol#: 729

C 9808 Lauren Rather Vol#: 729

C 9809 Ann Scott Root Vol#: 729

C 9810 David Carlson Vol#: 729

C 9811 Ellen Williams Vol#: 729

C 9812 not clear Vol#: 729

C 9813 Jane Gerald Vol#: 729

C 9814 Kellie Carbary Vol#: 729

C 9815 Eileen Carbary Vol#: 729

C 9816 Nora Kozloff Vol#: 729

C 9817 Patricia Stevens Vol#: 729

EMC 4499 Paul Iwasaki Vol#: 729

EMC 4500 David Sorensen Vol#: 729

EMC 4501 Frank Vacin Vol#: 729

EMC 4502 Susan Rudd Vol#: 729

EMC 4503 Linda Tseitlin Vol#: 729

EMC 4504 Russ Schnitzer Vol#: 729

EMC 4505 Sam Saal Vol#: 729

EMC 4506 Benjamin Smith Vol#: 729

EMC 4507 Beth Greenstein Vol#: 729

EMC 4508 Roy Overton Vol#: 729

EMC 4509 Justin Loper Vol#: 729

EMC 4510 Melanie N/A Vol#: 729

EMC 4511 Dean Atkinson Vol#: 729

00P-1472 Over-the-counter sodium phosphate bowel preparation products

LET 1 HFD-1 to Kleinfeld Kaplan & Bekcer Vol#: 1

00P-1535 Biopsy forceps covers/non-electric biopsy as Class I devices

C 2 MDMA, Medical Device Mfrs Assn. Vol#: 2

LET 1 Boston Scientific Corp. Vol#: 2

00P-1578 Safety of Med.Devices Mfg. with Silicone Catalyzed w/ Hexach

PDN 1 HFZ-1 to Michael R. Harbut, MD,MPH Vol#: 1

00Q-1582 Notification for Health Claims:Potassium Containing Foods

EC 1 Ms. Mary Jo Feeney Vol#: 2

00V-0980 Laser light show (Omniscan laser projection system)

VRA 2 HFZ-340 to Carnegie Science Center Vol#: 1

00V-1512 Laser light show

VRA 1 HFZ-340 to Steve White Vol#: 1

01D-0131 Hospitals,Nursing Homes, other Health Care Facilities

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

01D-0171 Content of Premarket Notifications for Automated Blood Separ

GDL 1 Advanced Medical Technology Association Vol#: 1

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

C 34 Randall C. Guthrie Vol#: 3

C 35 Sara-Jane Carey Vol#: 3

EMC 201 Rob & Susan Sunseri Vol#: 3

EMC 202 D. Mulerea Vol#: 3

EMC 203 Marianne Donadio Vol#: 3

EMC 204 Carol Dent Vol#: 3

01P-0148 Misbranding of reprocessed single use medical devices

C 1 Medical Devices Canada (MEDEC) Vol#: 1

01V-0080 Laser Light Show

VRA 1 HFZ-340 to Audio Climax Sound & Light Co Vol#: 1

01V-0082 Laser light show

VRA 1 HFZ-340 to Monaco Club Vol#: 1

01V-0088

VRA 1 HFZ-340 to Westwood Investment,LLC dba C Vol#: 1

01V-0101 Projector for laser light show model #REDLINE GP-8/G70

VRA 1 HFZ-340 to Sensory Ststems/Lightwave Vol#: 1

01V-0102 Laser light show projector

VRA 1 HFZ-340 to Nth Degree Creative Vol#: 1

01V-0110 Laser Light Show

VRA 1 HFZ-340 to OmniSistem Light and Effects Vol#: 1

01V-0172 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Prodigy Music, Inc. Vol#: 1