DOCKETS ENTERED on 06/15/01

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

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *

97N-0511 Procedures the safe and sanitary processing/importing juice *

98P-0151 Introduction Of Downed Cattle Into The Food Supply *

00D-1538 Electronic Records; Electronic Signatures, Validation *

00D-1598 Voluntary Labeling for Bioengineered Foods *

00N-1396 Bioengineered Foods Consumed By Humans or Animals *

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

00P-1322 Food Labeling and Allergen Contamination Control *

01D-0002 Regulatory Procedures Manual; Chapter 9; Import Operations *

01D-0044 Clinical Laboratory Improvement Amendments of 1988 *

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

01D-0192 Forms for registation of producers of drugs and listing of *

01N-0231 Verterinary adverse drug reaction, lack of effect, product *

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

01P-0169 Access & Safe Distribution of Alosetron *

01P-0230 Domestic Marketing & Importation of Transgenic Fish *

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

C 322 Jolene Churchill Vol#: 5

97N-0511 Procedures the safe and sanitary processing/importing juice

EXP 2 Am Frozen Food Institute et al Vol#: 31

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 4951 R. E. Penney Vol#: 156

C 4952 Kimberlie Wilcox Vol#: 156

C 4953 Sheila D. Williams Vol#: 156

C 4954 Globus & Cosmos World-Class Touring Worl Vol#: 156

C 4955 Mrs. Rita Flygar Vol#: 156

C 4956 Pam Nowak Vol#: 156

C 4957 Lesley Hill Vol#: 156

C 4958 The James Herrera Family Vol#: 156

C 4959 Tamara Chase Vol#: 156

C 4960 L. Elizabeth Cohan Vol#: 156

C 4961 Ms. Melissa O'Dell Vol#: 156

C 4962 Lynn H. Ehrle Vol#: 156

C 4963 Mrs. Gordon Vol#: 156

C 4964 Kris Baker Vol#: 156

C 4965 i. Peaches Vol#: 156

C 4966 E. L. Schwartz Vol#: 156

C 4967 Maria Harriton Vol#: 156

C 4968 R. Hoffman Vol#: 156

C 4969 Julie Stadtherr Vol#: 156

00D-1538 Electronic Records; Electronic Signatures, Validation

MM 7 HFC-240 & Industry Coalition (3/30/01) Vol#: 2

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

MM 7 HFC-240 & Industry Coalition (3/30/01) Vol#: 2

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

MM 7 HFC-240 & Industry Coalition (3/30/01) Vol#: 2

00D-1541 Electronic Signatures: Audit Trails

MM 7 HFC-240 & Industry Coalition (3/30/01) Vol#: 2

00D-1542 Electronic Signatures: Time Stamps

MM 7 HFC-240 & Industry Coalition (3/30/01) Vol#: 2

00D-1543 Electronic Signatures: Glossary of Terms

MM 7 HFC-240 & Industry Coalition (3/30/01) Vol#: 2

00D-1598 Voluntary Labeling for Bioengineered Foods

EMC 6101 Catherine Folkers Vol#: 313

00N-1256 Over-the-Counter Drug Products;Public Hearing

C 6 Steve Buyer (CI) Vol#: 24

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 3827 Thomas J. Taylor Vol#: 217

C 3828 Moreen R. Siegal Vol#: 217

C 3829 Gerry Kraft Vol#: 217

C 3830 Jane Herold Vol#: 217

C 3831 Mary Jo Long Vol#: 217

C 3832 Marshall McComb Vol#: 217

C 3833 Marilyn & Kenneth H. Jewell Vol#: 217

C 3834 Plesh Vol#: 217

C 3835 David Roederer Vol#: 217

C 3836 Forrest Perry Vol#: 217

C 3837 Lynn DiEuliis Vol#: 217

C 3838 Janice Randolph Vol#: 217

C 3839 Irl Stalcup Vol#: 217

C 3840 Mary Kuhlman-Hambrock Vol#: 217

C 3841 Diana Morton Vol#: 217

C 3842 James P. Elder Vol#: 217

C 3843 Marian P. Elder Vol#: 217

C 3844 Susan E. Elder Vol#: 217

C 3845 Jamie Danek Vol#: 217

C 3846 David, Julie & Charles Sheldon Vol#: 217

C 3847 S. M. Stevens Vol#: 217

C 3848 Augustus W. Merwin Vol#: 217

C 3849 Elizabeth Britton & Jonathan Bruno Vol#: 217

C 3850 Laura Holmquist Vol#: 217

C 3851 D. Crocker Vol#: 217

C 3852 K. Nelson Vol#: 217

C 3853 Jane Wakefield Vol#: 217

C 3854 Alan & Debra Centofante Vol#: 217

C 3855 Edward Hall Vol#: 217

C 3856 Joan P. Chalk Vol#: 217

C 3857 Ruth Redwick Vol#: 217

C 3858 Mr. & Mrs. R. Perna Vol#: 217

C 3859 Susan Ianniello Vol#: 217

C 3860 Suzanne Wigger Vol#: 217

C 3861 Patrick Lindley Vol#: 217

C 3862 Deborah S. Tyler Vol#: 217

C 3863 William G. Nagel Vol#: 217

C 3864 Gerry Fross Vol#: 217

C 3865 Michelle Ferrier Vol#: 217

C 3866 Dave Breder Vol#: 217

C 3867 Jennifer Zingler Vol#: 217

C 3868 Mary Ellen Rech Vol#: 217

C 3869 Dave Breder Vol#: 217

C 3870 Peter Williams Vol#: 217

C 3871 Heidi Williams Vol#: 217

C 3872 M. Kledt Vol#: 217

C 3873 Janis Ihrig Vol#: 217

C 3874 Kate Costello Vol#: 217

C 3875 Maria Slamanich Vol#: 217

C 3876 Turaj Zaimi Vol#: 217

C 3877 Sue M. Wiseman Vol#: 217

C 3878 Aileen Lanz Vol#: 217

C 3879 K. Wood Vol#: 217

C 3880 Andrea Rosen Vol#: 217

C 3881 Elaine Harrison Vol#: 217

C 3882 Barbara Frierson Vol#: 217

C 3883 unreadable Vol#: 217

C 3884 Deborah Marie Diamond Vol#: 217

C 3885 Susanna Black Vol#: 217

C 3886 Hector Black Vol#: 217

C 3887 Anges Black Vol#: 217

C 3888 Ruth A. Black Vol#: 217

C 3889 Lisa Thompson Vol#: 217

C 3890 Melance Rossa Vol#: 217

C 3891 Kevin Stockmann Vol#: 217

C 3892 Anne Ullmen Vol#: 217

C 3893 Morgan Farley Vol#: 217

C 3894 Marqueriti Matthews Vol#: 217

C 3895 Yvonne Hajda Vol#: 217

C 3896 Ms. Kathryn T. Ehlers Vol#: 217

C 3897 B. Edmonds Vol#: 217

C 3898 Sandra van Drimmelen Vol#: 217

C 3899 Paul Hershfield Vol#: 217

C 3900 Christine Cof Vol#: 217

C 3901 Betty J. Bazur Vol#: 217

C 3902 Aimee Cartier Vol#: 217

C 3903 Jeanne Easkman Vol#: 217

C 3904 Louis Molan Vol#: 217

C 3905 Deborah R. Osborne Vol#: 217

C 3906 Jenny Brundage Vol#: 217

C 3907 Dolores Daily Vol#: 217

C 3908 John Zehren Vol#: 217

C 3909 John St. Laurent Vol#: 217

C 3910 Tom Thoreau Vol#: 217

C 3911 Clifford Browder Vol#: 217

C 3912 Becca Harber Vol#: 217

C 3913 Orah Watson Vol#: 217

C 3914 Marianne Edain Vol#: 217

C 3915 L. Lakos Vol#: 217

C 3916 Diana Lalani Vol#: 217

C 3917 Christie Lercl Vol#: 217

C 3918 unreadable Vol#: 217

C 3919 Hawk Madrone Vol#: 217

C 3920 Christi Lindsey Vol#: 217

C 3921 Lisa Murphy Vol#: 217

C 3922 Ivan Kruh Vol#: 217

C 3923 K. O'Brien Vol#: 217

C 3924 Joseph Swain Vol#: 217

C 3925 Libby Tuttle Vol#: 217

C 3926 Geraldine Baca Vol#: 217

C 3927 Laura Barbour Vol#: 217

C 3928 Holly McNutt Vol#: 217

C 3929 David McNutt Vol#: 217

C 3930 Elizabeth Joiner Vol#: 217

C 3931 Carol Niedzialek Vol#:

C 3932 Jody Hill Vol#: 217

C 3933 Cindy Sessa Vol#: 217

C 3934 Helen Lawce Vol#: 217

C 3935 Brad Simonds Vol#: 217

C 3936 Benjamin Katz Vol#: 217

C 3937 Dan Plynn Vol#: 217

C 3938 Judith West Vol#: 217

C 3939 Barbara Foster Vol#: 217

C 3940 Warren & Olive Wilson Vol#: 217

C 3941 Tomoyuki Sumori Vol#: 217

C 3942 Julianne Douglas Vol#: 217

C 3943 Gloria Swan Vol#: 217

C 3944 Brooke Maher Vol#: 217

C 3945 Caroline Skinner Vol#: 217

C 3946 Jolene & Glen Trenkamp Vol#: 217

C 3947 Barbara Kesel Vol#: 217

C 3948 Marie-Claude Vuille Vol#: 217

C 3949 Nell M. Rodgers, RN, DC Vol#: 217

C 3950 Linda L. Woods Vol#: 217

C 3951 Patricia Alfano Vol#: 217

C 3952 Todd J. Binkley Vol#: 217

C 3953 Ron Dehaver Vol#: 217

C 3954 Joshua Huber Vol#: 217

C 3955 Tim Takaro Vol#: 217

C 3956 Ann A. Geddes Vol#: 217

C 3957 Jonathan Sellman, M.D. Vol#: 217

C 3958 Marjorie Lorenz Vol#: 217

C 3959 Marce L. Walsh Vol#: 217

C 3960 H. O. Andersen Vol#: 217

C 3961 N. Allison Tucker Vol#: 217

C 3962 Dan Cortsen Vol#: 217

C 3963 Larry Zimmerman Vol#: 217

C 3964 Brian, Lina & Christine Campopiano Vol#: 217

C 3965 Betsy Toll Vol#: 217

C 3966 Esther L. York Vol#: 217

C 3967 Nari Park Vol#: 217

C 3968 Eric Raun & Judy Seibert Vol#: 217

C 3969 Ruth Trout Vol#: 217

C 3970 Ruth Mangan Vol#: 217

C 3971 unreadable Vol#: 217

C 3972 E. M. Marcus Vol#: 217

C 3973 Michael Rochan Vol#: 217

C 3974 J. P. Mandy Vol#: 217

C 3975 Susan D. Levering Vol#: 217

C 3976 Dr. Judith Boice Vol#: 217

C 3977 Gale Latham Vol#: 217

C 3978 Diana Bright Vol#: 217

C 3979 E. J. Levy Vol#: 217

C 3980 M. M. Lippman, Ph.D. Vol#: 217

C 3981 Robert L. Neville Vol#: 217

C 3982 Lucille Joseph Vol#: 218

C 3983 Sandy Hagan Vol#: 218

C 3984 Catherine Sitzlow Vol#: 218

C 3985 Summer Mohammed Vol#: 218

C 3986 Susan C. Robinson, M.D., F.A.C.O.G. Vol#: 218

C 3987 Vicky Cosgrove Vol#: 218

C 3988 Margaret Nagel Vol#: 218

C 3989 Ellen Slater Vol#: 218

C 3990 unreadable Vol#: 218

C 3991 Lorena Unruh Vol#: 218

C 3992 Levon Hiatt Vol#: 218

C 3993 Maya Kaya Vol#: 218

C 3994 Denice Cristiano Vol#: 218

C 3995 Renee Mal Vol#: 218

C 3996 E. J. George Vol#: 218

C 3997 Vita Mones Vol#: 218

C 3998 Rochelle V. Costigan Vol#: 218

C 3999 unreadable Vol#: 218

C 4000 Barbara Bini Vol#: 218

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

C 12115 Cheryl L Hunter Vol#: 764

C 12116 Ana Richards Vol#: 764

C 12117 Fran Blumenstein Vol#: 764

C 12118 Cynthia A Baron Vol#: 764

C 12119 K Krause Vol#: 764

C 12120 M Mableitt Vol#: 764

C 12121 Emily Mansfield Vol#: 764

C 12122 Edwin Thomas Kosk Vol#: 764

C 12123 Sophie Morse Vol#: 764

C 12124 Oscar & Mavis Olson Vol#: 764

C 12125 Verna Helbuam Vol#: 764

C 12126 Beverly Relf Vol#: 764

C 12127 J Ruby Vol#: 764

C 12128 M Gordon Yaher Vol#: 764

C 12129 Patricia Durbin Vol#: 764

C 12130 The Frostad Family Vol#: 764

C 12131 Sean Colgan Vol#: 764

C 12132 Keui Moshenberg Vol#: 764

C 12133 Joni Coyote Vol#: 764

C 12134 Bob Romero Vol#: 764

C 12135 Johnnie Story Vol#: 764

C 12136 Dave Guimont Vol#: 764

C 12137 Judith Ann Cook Vol#: 764

C 12138 J Martino Vol#: 764

C 12139 Stephanie Fish Vol#: 764

C 12140 Luisa Rivosecchi Vol#: 764

C 12141 Angie Averett Vol#: 764

C 12142 Kathryn Donahoe Vol#: 764

C 12143 Alicia Pendar Vol#: 764

C 12144 Stacy Birindelli Vol#: 764

C 12145 Mrs John Brodeur Vol#: 764

C 12146 Martha Oakes Vol#: 764

C 12147 Linda Jackson Vol#: 764

C 12148 Gary Rice Vol#: 764

C 12149 Dorothy Mark Vol#: 764

C 12150 Rio Hibler-Kerr Vol#: 764

C 12151 Norma B Pearson Vol#: 764

C 12152 Mrs John Sachaczenski Vol#: 764

C 12153 Katie Campbell Vol#: 764

C 12154 Gladys Pistoruis Vol#: 764

C 12155 Faye Hudgins Vol#: 764

C 12156 Cynthia Hudgins Vol#: 764

C 12157 Kim Vanderschaaf Vol#: 764

C 12158 Anthony Martin Vol#: 764

C 12159 Erin Whetham Vol#: 764

C 12160 Judith Sims Vol#: 764

C 12161 Valerie Cap Vol#: 764

C 12162 Meldred Allen Ries Vol#: 764

C 12163 Rachel Griffiths Vol#: 764

C 12164 Keith Streid Vol#: 764

C 12165 Patricia K Knight Vol#: 764

C 12166 Janet Bean-Dochrahl Vol#: 764

C 12167 No name Vol#: 764

C 12168 Barbara Casey Vol#: 764

C 12169 Judy Godine Vol#: 764

C 12170 David Warren PhD & Marlene Matlock Vol#: 764

C 12171 Alan Timmerman Vol#: 764

C 12172 Laurie Cooper Vol#: 764

C 12173 Alice Shepherd Vol#: 764

C 12174 Sultan A-Ali Vol#: 764

C 12175 Margaret Pick Vol#: 764

C 12176 Richard Guinnell Vol#: 764

C 12177 Ms Leigh Williams Vol#: 764

C 12178 Charles J Guenther, Jr Vol#: 764

C 12179 John G Mills Vol#: 764

C 12180 Jeffrey J Peltz Vol#: 764

C 12181 Larry Peltz Vol#: 764

C 12182 Ben Sher + 1 name Vol#: 764

C 12183 Robert Peltz Vol#: 764

C 12184 Rita Levine Vol#: 764

C 12185 Marie M Heriveaux Vol#: 764

C 12186 Robert Ball Vol#: 764

C 12187 Sallie Corbin Vol#: 764

C 12188 Jim & Virginia Wagner Vol#: 764

C 12189 Margaret P Gilleo Vol#: 764

C 12190 Joanne Lind Vol#: 764

C 12191 Laura A Wolfsen Vol#: 764

C 12192 Margaret Hamper Vol#: 764

C 12193 Donna Britton Vol#: 764

C 12194 Georgette Deroche Vol#: 764

C 12195 Andra Levine Vol#: 764

C 12196 J W Lagler Vol#: 764

C 12197 Laurie Maly Vol#: 764

C 12198 Hal L Peebles Vol#: 764

C 12199 Roger Nurval Vol#: 764

C 12200 Maria Hope Vol#: 764

C 12201 Sara Halpern Vol#: 764

C 12202 Alexandra Eaks Vol#: 764

C 12203 Alex McLeod Vol#: 764

C 12204 Wendy Kram Vol#: 764

C 12205 J P Gagnon Vol#: 764

C 12206 Trisha Myers Vol#: 764

C 12207 Joan Clingan Vol#: 764

C 12208 Christina Hotea Vol#: 764

C 12209 Desirree Marlena Clonch Vol#: 764

C 12210 Andrea Laszlo Vol#: 764

C 12211 Summer Farnese Vol#: 764

C 12212 Jean Wyles MD Vol#: 764

C 12213 Jennifer Myrick Vol#: 764

C 12214 Elizabeth Eufemio Vol#: 764

C 12215 Joei Meissner Vol#: 764

C 12216 Ronald L Baker Vol#: 764

C 12217 Lynn Rhodes Vol#: 764

C 12218 Gene S Thomas Vol#: 764

C 12219 Diane Sansauer Vol#: 764

C 12220 R & C Stolarski Vol#: 764

C 12221 Maryann Harding Vol#: 764

C 12222 D Nichols Vol#: 764

C 12223 Myradis Tearsong Vol#: 764

C 12224 Caleb Aker Vol#: 764

C 12225 Jo Ann Witt Vol#: 764

C 12226 Marie C Sheehy Vol#: 764

C 12227 The Sligios Vol#: 764

C 12228 Carolyn Storey Vol#: 764

00P-1322 Food Labeling and Allergen Contamination Control

C 154 Catharine W Pope Vol#: 11

C 155 Patricia McGahan Vol#: 11

C 156 Dennis Donoghue Vol#: 11

C 157 Betty Barfield Vol#: 11

C 158 Matthew & Denise Palacek Vol#: 11

C 159 Inga Jackson Vol#: 11

C 160 Sarah Patterson Vol#: 11

C 161 Victoria Andersen Vol#: 11

C 162 Donna Steadman Vol#: 11

C 163 Catherine G Barr Vol#: 11

C 164 Carol Lydick Vol#: 11

00P-1499 Remove alosetron (Lotronex) from the market

C 67 Verna Eileen Radcliffe Vol#: 4

C 68 Charlotte Mayerson Vol#: 4

C 69 Hope Marcus Vol#: 4

C 70 Melissa D Godwin Vol#: 4

C 71 Karen Pelner Vol#: 4

C 72 Sally Read Vol#: 4

C 73 Marla Tidenberg Vol#: 4

01D-0002 Regulatory Procedures Manual; Chapter 9; Import Operations

C 1 National Coalition of Food Importing Ass Vol#: 1

01D-0044 Clinical Laboratory Improvement Amendments of 1988

C 32 National On-Site Testing Association Vol#: 3

C 33 Clinical Laboratory Improvement Advisory Vol#: 3

C 34 Genzyme Corporation Vol#: 3

C 35 CLIA Leadership in Clinical Systems Mgmt Vol#: 3

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

C 1 IHS Integrated Health Services Vol#: 1

C 2 Airgas Inc Vol#: 1

01D-0192 Forms for registation of producers of drugs and listing of

C 1 Bio Science Contract Production Corp Vol#: 1

01M-0270 On-X Prosthetic Heart Valve, Model ONXA P000037

AAV 1 Medical Carbon Research Institute LLC Vol#: 1

01M-0271 HealthTronics OssaTron, P990086

AAV 1 HealthTornics Inc Vol#: 1

01N-0231 Verterinary adverse drug reaction, lack of effect, product

EXT 1 Animal Health Institute Vol#: 1

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

C 166 Form letter count 261 Vol#: 8

01P-0169 Access & Safe Distribution of Alosetron

C 2 Hope Marcus Vol#: 1

C 3 Jan Busk Vol#: 1

C 4 Melissa D Godwin Vol#: 1

C 5 Sally Read Vol#: 1

C 6 Charlotte Mayerson Vol#: 1

C 7 Karen Pelner Vol#: 1

C 8 Kerri Ritchie Vol#: 1

C 9 Marla Tidenberg Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EMC 52 Form Letter Vol#: 7

EMC 53 Form Letter Vol#: 8