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 July 30, 2001

TABLE OF CONTENTS

Hyper links are part of the Docket  title - not all dockets/documents are linked

NOTE:  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.

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

 
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992 *
97N-0314 Prescription Drug Products; Levothyroxine Sodium *
99D-3028 Diagnosis/Monitoring of HCV infection/Associated disease *
99P-5106 Identify Sources of Natural Flavorings *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
01D-0162 Using FDA-Approved Patient Labeling in Consumer-Directed *
01D-0202 Provisions of the FDA Modernization Act of 1997 *
01D-0224 Mass Spectrometry for Confirmation of Identity of Animal Dru *
01N-0197 Treatment of Ankylosing Spondylitis and Related Disorders *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0248 Clarify Issues Relating to Patent Listings in "Orange Book" *
01P-0323 Not rely on non-public filings to approve an innovator NDA; *

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

ACK 2 HFA-305 Vol#: 236

CP 15 Bristol-Myers Squibb Vol#: 236

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

SUP 1 Pharmaceutical Distributors Association Vol#: 6

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

SUP 1 Pharmaceutical Distributors Association Vol#: 8

97N-0314 Prescription Drug Products; Levothyroxine Sodium

EMC 7 Jennifer Sellman SrA USAF Vol#: 1

EMC 8 Donald F Figliola Jr MD Vol#: 1

EMC 9 Thomas J Taylor MD Vol#: 1

EMC 10 Edy Rudnick Pineless Vol#: 1

EMC 11 Gloria Beliveau Vol#: 1

97P-0441 Regulatory Status of Cholestin red yeast rice

EMC 5 Cynthia S Holt Vol#: 15

98N-0337 Over the counter human drugs labeling requirements

APP 28 McNeil Consumer Healthcare Vol#: 8

APP 29 McNeil Consumer Healthcare Vol#: 8

CR 1 Perrigo Company Vol#: 8

99D-3028 Diagnosis/Monitoring of HCV infection/Associated disease

C 3 American Society for Microbiology Vol#: 1

C 4 Advanced Medical Technology Association Vol#: 1

C 5 Abbott Laboratories Vol#: 1

99P-5106 Identify Sources of Natural Flavorings

EMC 111 Sunjay D Trehan Vol#: 1

EMC 112 Christina Ford Vol#: 1

EMC 113 Chris Toomer Vol#: 1

EMC 114 Southern Voter Vol#: 1

EMC 115 Elsa Wright Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

MM 8 HFC-240 & Quamas Inc (2/23/01) Vol#: 2

MM 9 HFC-240 & Wimmer Systems Inc (3/07/01) Vol#: 2

MM 10 HFC-240 & NetRegulus (4/23/01) Vol#: 2

MM 11 HFC-240 & Datasweep Inc (5/16/01) Vol#: 2

MM 12 HFC-240 & ProPackData Corp. (6/14/01) Vol#: 2

MM 13 HFC-240 & PDA/ISPE/GAMP (5/23/01) Vol#: 2

RPT 4 UK, Management, Appraisal & Preservation Vol#: 3

RPT 5 UK, ERM Systems Evaluation Scheme Vol#: 4

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

MM 8 HFC-240 & Quamas Inc (2/23/01) Vol#: 2

MM 9 HFC-240 & Wimmer Systems Inc (3/07/01) Vol#: 2

MM 10 HFC-240 & NetRegulus (4/23/01) Vol#: 2

MM 11 HFC-240 & Datasweep Inc (5/16/01) Vol#: 2

MM 12 HFC-240 & ProPackData Corp. (6/14/01) Vol#: 2

MM 13 HFC-240 & PDA/ISPE/GAMP (5/23/01) Vol#: 2

RPT 4 UK, Management, Appraisal & Preservation Vol#: 3

RPT 5 UK, ERM Systems Evaluation Scheme Vol#: 4

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

MM 8 HFC-240 & Quamas Inc (2/23/01) Vol#: 2

MM 9 HFC-240 & Wimmer Systems Inc (3/07/01) Vol#: 2

MM 10 HFC-240 & NetRegulus (4/23/01) Vol#: 2

MM 11 HFC-240 & Datasweep Inc (5/16/01) Vol#: 2

MM 12 HFC-240 & ProPackData Corp. (6/14/01) Vol#: 2

MM 13 HFC-240 & PDA/ISPE/GAMP (5/23/01) Vol#: 2

RPT 4 UK, Management, Appraisal & Preservation Vol#: 3

RPT 5 UK, ERM Systems Evaluation Scheme Vol#: 4

00D-1541 Electronic Signatures: Audit Trails

MM 8 HFC-240 & Quamas Inc (2/23/01) Vol#: 2

MM 9 HFC-240 & Wimmer Systems Inc (3/07/01) Vol#: 2

MM 10 HFC-240 & NetRegulus (4/23/01) Vol#: 2

MM 11 HFC-240 & Datasweep Inc (5/16/01) Vol#: 2

MM 12 HFC-240 & ProPackData Corp. (6/14/01) Vol#: 2

MM 13 HFC-240 & PDA/ISPE/GAMP (5/23/01) Vol#: 2

RPT 4 UK, Management, Appraisal & Preservation Vol#: 3

RPT 5 UK, ERM Systems Evaluation Scheme Vol#: 4

00D-1542 Electronic Signatures: Time Stamps

MM 8 HFC-240 & Quamas Inc (2/23/01) Vol#: 2

MM 9 HFC-240 & Wimmer Systems Inc (3/07/01) Vol#: 2

MM 10 HFC-240 & NetRegulus (4/23/01) Vol#: 2

MM 11 HFC-240 & Datasweep Inc (5/16/01) Vol#: 2

MM 12 HFC-240 & ProPackData Corp. (6/14/01) Vol#: 2

MM 13 HFC-240 & PDA/ISPE/GAMP (5/23/01) Vol#: 2

RPT 4 UK, Management, Appraisal & Preservation Vol#: 3

RPT 5 UK, ERM Systems Evaluation Scheme Vol#: 4

00D-1543 Electronic Signatures: Glossary of Terms

MM 8 HFC-240 & Quamas Inc (2/23/01) Vol#: 2

MM 9 HFC-240 & Wimmer Systems Inc (3/07/01) Vol#: 2

MM 10 HFC-240 & NetRegulus (4/23/01) Vol#: 2

MM 11 HFC-240 & Datasweep Inc (5/16/01) Vol#: 2

MM 12 HFC-240 & ProPackData Corp. (6/14/01) Vol#: 2

MM 13 HFC-240 & PDA/ISPE/GAMP (5/23/01) Vol#: 2

RPT 4 UK, Management, Appraisal & Preservation Vol#: 3

RPT 5 UK, ERM Systems Evaluation Scheme Vol#: 4

00D-1598 Voluntary Labeling for Bioengineered Foods

C 5892 C. Vrankow Vol#: 406

C 5893 Sid Chait Vol#: 406

C 5894 Peggy Wojclk Dunbar Vol#: 406

C 5895 Karen Thelen Vol#: 406

C 5896 Jonathan Bona Vol#: 406

C 5897 Joan E. Benton Vol#: 406

C 5898 Stephen Antupit Vol#: 406

C 5899 Richard Morris Vol#: 406

C 5900 Judith N. Stepan Vol#: 406

C 5901 S. Jared Vol#: 406

C 5902 Martha Pfleeler Vol#: 406

C 5903 Grant Warrens Vol#: 406

C 5904 Marc Levine Vol#: 406

C 5905 A.G. Pessah Vol#: 406

C 5906 Hans Frederick Vol#: 406

C 5907 Deanna L. May Vol#: 406

C 5908 Sherry Shaffer Vol#: 406

C 5909 B.J. Oliver Vol#: 406

C 5910 J. Tieger Vol#: 406

C 5911 Pamela Glass Vol#: 406

C 5912 Tina Hacker Vol#: 406

C 5913 Tony Smith Vol#: 406

C 5914 Leslie Smith Vol#: 408

C 5915 M. E. Rech Vol#: 408

C 5916 Lynn M. Smith Vol#: 408

C 5917 Michelle Maurer Vol#: 408

C 5918 Justin Tisdale Vol#: 408

C 5919 David Mitchell Vol#: 408

C 5920 Monica Vigel Vol#: 408

C 5921 G. Ozsvath Vol#: 408

C 5922 A. Terrell Vol#: 408

C 5923 Kay Lightner Vol#: 408

C 5924 Lew Wallach Vol#: 408

C 5925 P. Grotte-Higley Vol#: 408

C 5926 Erin Eastridge Vol#: 408

C 5927 Prudeuce Page Vol#: 408

C 5928 Joy Schawuschean Vol#: 408

C 5929 S.C. Darsee Vol#: 408

C 5930 Suzanne & James Hruschka Vol#: 408

C 5931 Angelina Jaques Vol#: 408

C 5932 Elizabeth Neves Vol#: 408

C 5933 Stanley Junior Vol#: 408

C 5934 Lynn Buck Vol#: 408

C 5935 Rajaa Muhammed Vol#: 408

C 5936 Esther Leisher Vol#: 408

C 5937 Shirley Thieda Skipworth Vol#: 408

C 5938 Greta McDonald Vol#: 408

C 5939 Cynthia M. Ruybal Vol#: 408

C 5940 Jennifer Singleterry Vol#: 408

C 5941 Jeanne Shannon Vol#: 408

C 5942 Celina Curie Vol#: 408

C 5943 Isaac L. Hudson Vol#: 408

C 5944 Terra Kelsey Vol#: 408

C 5945 David Middleton Vol#: 408

C 5946 Maria Panone Vol#: 408

C 5947 Diane Shenk Vol#: 408

C 5948 Jan Tredway Vol#: 408

C 5949 Byron Tredway Vol#: 408

C 5950 Patty Adams Vol#: 408

C 5951 Janet Range Vol#: 408

C 5952 Gabi Rain Freeman Vol#: 408

C 5953 Sharon Steely Vol#: 408

C 5954 J.A. Harp Vol#: 408

C 5955 Eligible Vol#: 408

C 5956 Mr & Mrs Marvin Rapoport Vol#: 408

C 5957 Al Metzger Vol#: 408

C 5958 K. Madolyn Nichols Vol#: 408

C 5959 Phyllis Baumann Vol#: 408

C 5960 Harris Boebel Vol#: 408

C 5961 Amy Hornbeas Vol#: 408

C 5962 Barbara Fess Vol#: 408

C 5963 Amy Williams Vol#: 408

C 5964 Margaret Kankol Vol#: 408

C 5965 Loren Fennell Vol#: 408

C 5966 Bernice Kruger Vol#: 408

C 5967 Karen D. Johnson, RN Vol#: 408

C 5968 John Thibodeau Vol#: 408

C 5969 No Signature Vol#: 408

C 5970 K. Johnson, RN Vol#: 408

C 5971 Nicole Bradley Vol#: 408

C 5972 Eligible Vol#: 408

C 5973 Mrs. Faureario de Bourebore Vol#: 408

C 5974 Stephen G. Smith Vol#: 408

C 5975 Fay Benson Vol#: 408

C 5976 Cole Kojak Vol#: 408

C 5977 Sandra Kristal Vol#: 408

C 5978 J. Schwartz Vol#: 408

C 5979 Pina Noto Vol#: 408

C 5980 Sean O'Flynn Vol#: 408

C 5981 Chris Stark Vol#: 408

C 5982 V.M. Weber Vol#: 408

C 5983 Carolyn Loomis Vol#: 408

C 5984 JoAnn Ross Vol#: 408

C 5985 Omar Bubaedi Vol#: 408

C 5986 Jeanne Considine Vol#: 408

C 5987 C. Perlingieri Vol#: 408

C 5988 Eric Zeitlin Vol#: 408

C 5989 Diane Lawson Vol#: 408

C 5990 Janet Grenslitt Vol#: 408

C 5991 David Lewis Vol#: 408

C 5992 Courtney Bloodgood Vol#: 408

C 5993 Lindsay Bailey Vol#: 408

C 5994 Edmond Knighton Vol#: 408

C 5995 Lisa Smith Vol#: 408

C 5996 Jody Gates Vol#: 408

C 5997 Alexandria Ramsay Vol#: 408

C 5998 Linda Norgol Vol#: 408

C 5999 Ed Wise Vol#: 408

C 6000 Deborah Jones Vol#: 408

C 6001 Sharon R. Mayo Vol#: 408

C 6002 Gillian Ehrlich Vol#: 408

C 6003 Roberta W. Diye Vol#: 408

C 6004 Alison R. Moss Vol#: 408

C 6005 Justine K. Buisson Vol#: 408

C 6006 Deborah Hedden Vol#: 408

C 6007 Bonnie Johnstone Vol#: 408

C 6008 Allen D. Frankel Vol#: 408

C 6009 Joan Schmitz Vol#: 408

C 6010 David Karas Vol#: 408

C 6011 Patricia and Frederick Wildes Vol#: 408

C 6012 Chris Beeson Vol#: 408

C 6013 Barbara R. Lilly Vol#: 408

C 6014 Hallie Whitcomb Vol#: 408

C 6015 Earl G. Jacob Vol#: 408

C 6016 Patricia Thomas Vol#: 408

C 6017 William Russell Vol#: 408

C 6018 Sheryl Swett Vol#: 408

C 6019 A.J. Brass Vol#: 408

C 6020 Inge Szucs Vol#: 408

C 6021 Beatrice M. Ardohain Vol#: 408

C 6022 J.O'Donnell Vol#: 408

C 6023 Ann Kremers Vol#: 408

C 6024 Ann McClain Vol#: 408

C 6025 Laurie Lundgren Vol#: 408

C 6026 Scott Atthowe Vol#: 408

C 6027 Charles A. Kerschner Vol#: 408

C 6028 Peter E. Langr Vol#: 408

C 6029 Betty Vol#: 408

C 6030 Alice Tseng Vol#: 408

C 6031 Barbara Christie Vol#: 408

C 6032 Cynthia Lynne Vol#: 408

C 6033 Christina D. Witkowski Vol#: 410

C 6034 Ellen Baker Vol#: 410

C 6035 Nancy & Antonio Nieman Vol#: 410

C 6036 Ross Gienger Vol#: 410

C 6037 Martha M. Davis Vol#: 410

C 6038 Joanne Burrows & Alexis Penn Vol#: 410

C 6039 Elaine Hirson Vol#: 410

C 6040 Kem Epperson Vol#: 410

C 6041 Sue Herring Vol#: 410

C 6042 Cynthia Wutchiett Vol#: 410

C 6043 Lois D. Christensen Vol#: 410

C 6044 Robin Miller Vol#: 410

C 6045 Carol Cushing Vol#: 410

C 6046 Cindy Mathias Vol#: 410

C 6047 Dan Leary Vol#: 410

C 6048 George Fitzgerald Vol#: 410

C 6049 Fred & Dorothea Saeger Vol#: 410

C 6050 Jane Howard Vol#: 410

C 6051 Janet Lucius Vol#: 410

C 6052 L. Heard Vol#: 410

C 6053 Sarah Henyan Vol#: 410

C 6054 Andy Obrien Vol#: 410

C 6055 Katherine Miskey Vol#: 410

C 6056 John Tyler Vol#: 410

C 6057 No Signature Vol#: 410

C 6058 Steven O. App Vol#: 410

C 6059 H. Roth Vol#: 410

C 6060 Katherine Bradrick Vol#: 410

C 6061 Amy Woods Vol#: 410

C 6062 Carolyn N. Fitzger Vol#: 410

C 6063 Natalie Pelc Vol#: 410

C 6064 Karen Pedler Vol#: 410

C 6065 Betty Stounbaugh Vol#: 410

C 6066 Michael Henningsen Vol#: 410

C 6067 Richard Mullen Vol#: 410

C 6068 Wild Oats Market, Inc. Vol#: 410

C 6069 Robin Joy Wellman Vol#: 410

C 6070 Dan Nosherry Vol#: 410

C 6071 Barbara Glover Vol#: 410

C 6072 Marian Blankenship Vol#: 410

C 6073 Tim Bruhns Vol#: 410

C 6074 Neal Smith Vol#: 410

C 6075 Don Park Vol#: 410

C 6076 Pierie Ternay Vol#: 410

C 6077 Elaine Woods Vol#: 410

C 6078 Maggi Jane Vol#: 410

C 6079 Elaine Partlow Vol#: 410

C 6080 A. McCoy Vol#: 410

EMC 9801 Sudha Ramasamy Vol#: 409

EMC 9802 Susan Claymore Vol#: 409

EMC 9803 Susan Claymore Vol#: 409

EMC 9804 Janet Gottlieb Vol#: 409

EMC 9805 Janet Gottlieb Vol#: 409

EMC 9806 John Blanco Vol#: 409

EMC 9807 Donna Clark Vol#: 409

EMC 9808 John McConnell Vol#: 409

EMC 9809 John McConnell Vol#: 409

EMC 9810 Amanda Babson Vol#: 409

EMC 9811 Dick & Sally Dunbar Vol#: 409

EMC 9812 Jennifer McEwen Vol#: 409

EMC 9813 Richard Boyce, Jr. Vol#: 409

EMC 9814 Richard Boyce, Jr. Vol#: 409

EMC 9815 Deborah Kenny Vol#: 409

EMC 9816 Deborah Kenny Vol#: 409

EMC 9817 Doris Baker Vol#: 409

EMC 9818 Peter C. Doyle Vol#: 409

EMC 9819 Kate Conetta Vol#: 409

EMC 9820 Kate Conetta Vol#: 409

EMC 9821 Catherine Schwering Vol#: 409

EMC 9822 Michael Pierce McKeever, Sr. Vol#: 409

EMC 9823 Michael Pierce McKeever, Sr. Vol#: 409

EMC 9824 Ericka Small Vol#: 409

EMC 9825 Ericka Small Vol#: 409

EMC 9826 Cheryl Hirsch Vol#: 409

EMC 9827 Cheryl Hirsch Vol#: 409

EMC 9828 David Kerr Vol#: 409

EMC 9829 Agnes Meysenburg Vol#: 409

EMC 9830 Steve Carlson, Environmental Consultant Vol#: 409

EMC 9831 Nathan Davis Vol#: 409

EMC 9832 Magi Mooney Vol#: 409

EMC 9833 Marianne O'Brien Vol#: 409

EMC 9834 Marianne O'Brien Vol#: 409

EMC 9835 Martha White Vol#: 409

EMC 9836 Claudia Gdaniec Vol#: 409

EMC 9837 Claudia Gdaniec Vol#: 409

EMC 9838 Scot Shatwell Vol#: 409

EMC 9839 Ariel Spaeth Vol#: 409

EMC 9840 David Clarkin Vol#: 409

EMC 9841 Jessica DePete Vol#: 409

EMC 9842 Jessica DePete Vol#: 409

EMC 9843 Karen Dunn Vol#: 409

EMC 9844 Karen Dunn Vol#: 409

EMC 9845 Jami Finkbeiner Vol#: 409

EMC 9846 Jami Finkbeiner Vol#: 409

EMC 9847 Aaron Bowen Vol#: 409

EMC 9848 Aaron Bowen Vol#: 409

EMC 9849 Erb Avore', CEO, Liberty Financial Servi Vol#: 409

EMC 9850 Nancy Taiani Vol#: 409

EMC 9851 Alex Lazar Vol#: 409

EMC 9852 ShannaLee Horvik Vol#: 409

EMC 9853 Kathleen Wacholtz Vol#: 409

EMC 9854 Kathleen Wacholtz Vol#: 409

EMC 9855 Patricia E. Pitman Vol#: 409

EMC 9856 L Sloane Vol#: 409

EMC 9857 L Sloane Vol#: 409

EMC 9858 James Marzano Vol#: 409

EMC 9859 Peter A. Winkler Vol#: 409

EMC 9860 Megan McDonald Vol#: 409

EMC 9861 Megan McDonald Vol#: 409

EMC 9862 Amanda Fuller Vol#: 409

EMC 9863 Amanda Fuller Vol#: 409

EMC 9864 Barbara Roettger Vol#: 409

EMC 9865 David Carter Vol#: 409

EMC 9866 David Carter Vol#: 409

EMC 9867 Scott H. Segal Vol#: 409

EMC 9868 Ernst Kaemke Vol#: 409

EMC 9869 Ernst Kaemke Vol#: 409

EMC 9870 Joan Realino-Robinson Vol#: 409

EMC 9871 Joan Realino-Robinson Vol#: 409

EMC 9872 David Bixby Vol#: 409

EMC 9873 David Bixby Vol#: 409

EMC 9874 Stephanie Mertens, ASC Vol#: 409

EMC 9875 Kathleen Watson Vol#: 409

EMC 9876 Kathleen Watson Vol#: 409

EMC 9877 J Jacobson Vol#: 409

EMC 9878 Billy & Loretta Bryant Vol#: 409

EMC 9879 Billy & Loretta Bryant Vol#: 409

EMC 9880 Jeffrey and Stasia Wussow Vol#: 409

EMC 9881 Wilma Bryant Vol#: 409

EMC 9882 Wilma Bryant Vol#: 409

EMC 9883 Christina Beard Vol#: 409

EMC 9884 Christina Beard Vol#: 409

EMC 9885 David Glazener Vol#: 409

EMC 9886 David Glazener Vol#: 409

EMC 9887 Anthony Harris Vol#: 409

EMC 9888 Anthony Harris Vol#: 409

EMC 9889 Sara Reynolds Vol#: 409

EMC 9890 Sara Reynolds Vol#: 409

EMC 9891 Eleanor Runnion Vol#: 409

EMC 9892 Eleanor Runnion Vol#: 409

EMC 9893 Elizabeth Schrader Vol#: 409

EMC 9894 Elizabeth Schrader Vol#: 409

EMC 9895 Eleanor Runnion Vol#: 409

EMC 9896 Eleanor Runnion Vol#: 409

EMC 9897 Wilma Stephenson Vol#: 409

EMC 9898 Wilma Stephenson Vol#: 409

EMC 9899 Giovanni Angello Vol#: 409

EMC 9900 Monica Wormington Vol#: 409

EMC 9901 Roberta Ann Gruber Vol#: 409

EMC 9902 Roberta Ann Gruber Vol#: 409

EMC 9903 Nancy Cochran Vol#: 409

EMC 9904 Nancy Cochran Vol#: 409

EMC 9905 S. Batchelor Vol#: 409

EMC 9906 S. Batchelor Vol#: 409

EMC 9907 Tamara Muller Vol#: 409

EMC 9908 Tamara Muller Vol#: 409

EMC 9909 Russelle Baltzell Vol#: 409

EMC 9910 Christopher Goldson Vol#: 409

EMC 9911 Christopher Goldson Vol#: 409

EMC 9912 Eugene M. Herman Vol#: 409

EMC 9913 Hunter Francis Vol#: 409

EMC 9914 Hunter Francis Vol#: 409

EMC 9915 Mary Lu Lageman Vol#: 409

EMC 9916 Nancy Keane Vol#: 409

EMC 9917 Nancy Keane Vol#: 409

EMC 9918 Heather Logsdon Vol#: 409

EMC 9919 Bob Beaudry Vol#: 409

EMC 9920 Bob Beaudry Vol#: 409

EMC 9921 Scott M. Brenneisen Vol#: 409

EMC 9922 Amy Toren Vol#: 409

EMC 9923 Montgomery Toren Vol#: 409

EMC 9924 Sasha Kintzler Vol#: 409

EMC 9925 Sasha Kintzler Vol#: 409

EMC 9926 Ms Avery Hart, MA, MSW, LCSW Vol#: 409

EMC 9927 Kristen Kosidowski Vol#: 409

EMC 9928 Kristen Kosidowski Vol#: 409

EMC 9929 unsigned Vol#: 409

EMC 9930 Audrey Chase Vol#: 409

EMC 9931 Diane Melin Vol#: 409

EMC 9932 Chuck McDougal Vol#: 409

EMC 9933 Ross Sweatman Vol#: 409

EMC 9934 Jeffrey Sousa Vol#: 409

EMC 9935 Iona Singleton Vol#: 409

EMC 9936 Stella M. Aleman de Gallardo Vol#: 409

EMC 9937 Gloria J. Dickson, DVM Vol#: 409

EMC 9938 Louise Dechant Vol#: 409

EMC 9939 Louise Dechant Vol#: 409

EMC 9940 Gaye Unverferth Vol#: 409

EMC 9941 Gaye Unverferth Vol#: 409

EMC 9942 Lynette Bowers Vol#: 409

EMC 9943 Kevin Bowers Vol#: 409

EMC 9944 Jon-Paul Maurin Vol#: 409

EMC 9945 Theresa Cady Vol#: 409

EMC 9946 Theresa Cady Vol#: 409

EMC 9947 Lee Cohen Vol#: 409

EMC 9948 Lee Cohen Vol#: 409

EMC 9949 Matthew Chojnacki Vol#: 409

EMC 9950 Matthew Chojnacki Vol#: 409

EMC 9951 unsigned Vol#: 409

EMC 9952 unsigned Vol#: 409

EMC 9953 Deirdre Mallon Vol#: 409

EMC 9954 Gwendolyn Thomson Vol#: 409

EMC 9955 Gwendolyn Thomson Vol#: 409

EMC 9956 Wendy Mason Vol#: 409

EMC 9957 Elizabeth Edmonson Vol#: 409

EMC 9958 Elizabeth Edmonson Vol#: 409

EMC 9959 Sherman Kane Vol#: 409

EMC 9960 Sherman Kane Vol#: 409

EMC 9961 Douglas Remington Vol#: 409

EMC 9962 S M Severina Caron Vol#: 409

EMC 9963 Ian Godwin Vol#: 409

EMC 9964 Ian Godwin Vol#: 409

EMC 9965 A. Wyndham Vol#: 409

EMC 9966 Christina Confalone Vol#: 409

EMC 9967 Tenesh Webber Vol#: 409

EMC 9968 Tenesh Webber Vol#: 409

EMC 9969 Lois Barbour Vol#: 409

EMC 9970 Lois Barbour Vol#: 409

EMC 9971 Jan Vincent Vol#: 409

EMC 9972 Jan Vincent Vol#: 409

EMC 9973 Dan, Donna Amanda, and Danny Davis Vol#: 409

EMC 9974 Kristen Slorah Vol#: 409

EMC 9975 Susan Prager Vol#: 409

EMC 9976 Robert Stevens Vol#: 409

EMC 9977 Robert Stevens Vol#: 409

EMC 9978 Mark Stevens Vol#: 409

EMC 9979 Mark Stevens Vol#: 409

EMC 9980 Lori Wilkinson Vol#: 409

EMC 9981 Tamara Adkins-Bates Vol#: 409

EMC 9982 Sandra Schanzer Vol#: 409

EMC 9983 Derek Campbell Vol#: 409

EMC 9984 Rob Morrison Vol#: 409

EMC 9985 Rob Morrison Vol#: 409

EMC 9986 Tom Musgrave Vol#: 409

EMC 9987 Tom Musgrave Vol#: 409

EMC 9988 Kimberlee Williamson Vol#: 409

EMC 9989 Kimberlee Williamson Vol#: 409

EMC 9990 Christina Finlayson Vol#: 409

EMC 9991 Christina Finlayson Vol#: 409

EMC 9992 Julie Ota Vol#: 409

EMC 9993 Julie Ota Vol#: 409

EMC 9994 Johanna Thunemann Vol#: 409

EMC 9995 Brian Kennedy Vol#: 409

EMC 9996 Chad Binder Vol#: 409

EMC 9997 Tracy McLellan Vol#: 409

EMC 9998 Tracy McLellan Vol#: 409

EMC 9999 Mary J. Boote Vol#: 409

EMC 10000 Karin Husmann Vol#: 409

EMC 10001 Dorothy Vol#: 409

EMC 10002 Susan Rinaldi Vol#: 409

EMC 10003 Johanna Best Vol#: 409

EMC 10004 Johanna Best Vol#: 409

EMC 10005 Sonja Martin Vol#: 409

EMC 10006 Sonja Martin Vol#: 409

EMC 10007 Daniel Jaffee Vol#: 409

EMC 10008 Daniel Jaffee Vol#: 409

EMC 10009 Brian Heinrich Vol#: 409

EMC 10010 Brian Heinrich Vol#: 409

EMC 10011 Paul Jon Plyler Vol#: 409

EMC 10012 Kim Woodward Vol#: 409

EMC 10013 Annie Chapman Vol#: 409

EMC 10014 Erica Page Vol#: 409

EMC 10015 Theresa Allan Vol#: 409

EMC 10016 Theresa Allan Vol#: 409

EMC 10017 Nancy Viens Vol#: 409

EMC 10018 Nancy Viens Vol#: 409

EMC 10019 Sharon Andrew Vol#: 409

EMC 10020 Suzanne Slezak Vol#: 409

EMC 10021 Suzanne Slezak Vol#: 409

EMC 10022 David Jarrett Vol#: 409

EMC 10023 Nicole Levinson Vol#: 409

EMC 10024 Nicole Levinson Vol#: 409

EMC 10025 Joan Yakimik Vol#: 409

EMC 10026 unsigned Vol#: 409

EMC 10027 Michael Diamond Vol#: 409

EMC 10028 Nicholas Edman Vol#: 409

EMC 10029 Nicholas Edman Vol#: 409

EMC 10030 Valerie Graham Vol#: 409

EMC 10031 Thomas B. Hatcher Vol#: 409

EMC 10032 Thomas B. Hatcher Vol#: 409

EMC 10033 Sonia Bermudez Vol#: 409

EMC 10034 Sonia Bermudez Vol#: 409

EMC 10035 Dawn Stutzman Vol#: 409

00N-0074 Safeguards for Children Clinical Ivestigations FDA-Regulated

C 10 Temple University School of Pharmacy-Int Vol#: 1

C 11 National Institutes of Health (NIH) Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 9770 g a Vol#: 263

EMC 9771 Jerry Gershenhorn Vol#: 263

EMC 9772 Mimi Maloney Vol#: 263

EMC 9773 Number not used Vol#: 263

EMC 9774 Beverly B. Ferguson Vol#: 263

EMC 9775 Michael Menichetti Vol#: 263

EMC 9776 Michael Menichetti Vol#: 263

EMC 9777 Hugh Bailey Vol#: 263

EMC 9778 Tom Travis Vol#: 263

EMC 9779 John Schober Vol#: 263

EMC 9780 Susan "Freshspirit" Vol#: 263

EMC 9781 Sandie Hanson-Bjornson Vol#: 263

EMC 9782 Skye Leith Vol#: 263

EMC 9783 Kelly Cannata Vol#: 263

EMC 9784 C.L. Anderson & G.F. Bergman Jr. Vol#: 263

EMC 9785 Annemarie Colbin Vol#: 263

EMC 9786 Annemarie Colbin Vol#: 263

EMC 9787 Chris Wrinn Vol#: 263

EMC 9788 Kateri Meyer Vol#: 263

EMC 9789 Ennupoiss@aol.com Vol#: 263

EMC 9790 Angela & Doug Parker-Simkin Vol#: 263

EMC 9791 Marlin Anderson Vol#: 263

EMC 9792 Sharon Henderson Vol#: 263

EMC 9793 Mark Rosen Vol#: 263

EMC 9794 John Sims Vol#: 263

EMC 9795 K Marsh Vol#: 263

EMC 9796 Annie Degen Vol#: 263

EMC 9797 Julie Hudson Vol#: 263

EMC 9798 Kimberly Dodd Vol#: 263

EMC 9799 Theresa Gallagher Vol#: 263

EMC 9800 Theresa Gallagher Vol#: 263

EMC 9801 Jim Dawson Vol#: 264

EMC 9802 Paul Chubbuck Vol#: 264

EMC 9803 Ruth Margolis Vol#: 264

EMC 9804 Jerry Landay Vol#: 264

EMC 9805 John Allen Vol#: 264

EMC 9806 John Allen Vol#: 264

EMC 9807 Dennis Hull Vol#: 264

EMC 9808 Jeffrey C. Guntzell & Soyun Kim Vol#: 264

EMC 9809 Erin MacDonald Vol#: 264

EMC 9810 Marylyn P. Pauley Vol#: 264

EMC 9811 Peter LeClair Vol#: 264

EMC 9812 Paul Larson Vol#: 264

EMC 9813 Donna Cassano Vol#: 264

EMC 9814 Kathleen Smith Vol#: 264

EMC 9815 Kathleen Smith Vol#: 264

EMC 9816 Noah Hiken Vol#: 264

EMC 9817 Eve Cholmar Vol#: 264

EMC 9818 Betty Doshier/Backer Vol#: 264

EMC 9819 Suzanne Glass Vol#: 264

EMC 9820 Suzanne Glass Vol#: 264

EMC 9821 Gretchen Bomboy Vol#: 264

EMC 9822 Trina Paulus Vol#: 264

EMC 9823 Susan Tufts-Moore Vol#: 264

EMC 9824 Trent Elwing Vol#: 264

EMC 9825 Karen Walby Vol#: 264

EMC 9826 Karen Eubanks Vol#: 264

EMC 9827 Stephanie McFarland Vol#: 264

EMC 9828 Sharon Duguay Vol#: 264

EMC 9829 Sharon Duguay Vol#: 264

EMC 9830 Simha Carroll Vol#: 264

EMC 9831 David Dillard Vol#: 264

EMC 9832 Carol Waddington Vol#: 264

EMC 9833 Carol Waddington Vol#: 264

EMC 9834 Doreen Miller Vol#: 264

EMC 9835 Doreen Miller Vol#: 264

EMC 9836 Lyle Nash Vol#: 264

EMC 9837 Carla Pestana Vol#: 264

EMC 9838 Carla Pestana Vol#: 264

EMC 9839 Mike Tetrault Vol#: 264

EMC 9840 A Consumer Vol#: 264

EMC 9841 E John Fallon Vol#: 264

EMC 9842 E John Fallon Vol#: 264

EMC 9843 Shane Boosey Vol#: 264

EMC 9844 Shane Boosey Vol#: 264

EMC 9845 Bryce Nesbitt Vol#: 264

EMC 9846 Paula Merritt Vol#: 264

EMC 9847 Paula Merritt Vol#: 264

EMC 9848 Grace & Bruce Lyon Vol#: 264

EMC 9849 P. McCullough Vol#: 264

EMC 9850 Stephen Horvath Vol#: 264

EMC 9851 Stephen Horvath Vol#: 264

EMC 9852 Jann Biggs-McNaughton Vol#: 264

EMC 9853 Jann Biggs-McNaughton Vol#: 264

EMC 9854 Kati Holland Vol#: 264

EMC 9855 R Diddens Vol#: 264

EMC 9856 Faye Slice Vol#: 264

EMC 9857 Faye Slice Vol#: 264

EMC 9858 Lee Shinefield Vol#: 264

EMC 9859 Genevieve Sprinkle Vol#: 264

EMC 9860 Genevieve Sprinkle Vol#: 264

EMC 9861 Lisa & Paul Anderson Vol#: 264

EMC 9862 Mary Kay Craig Vol#: 264

EMC 9863 Mary Kay Craig Vol#: 264

EMC 9864 Chris Watson Vol#: 264

EMC 9865 Diane E. Hauhn Vol#: 264

EMC 9866 Jane Ratchford Vol#: 264

EMC 9867 Karin Edwards Vol#: 264

EMC 9868 Karin Edwards Vol#: 264

EMC 9869 Art & Cindy Strauss Vol#: 264

EMC 9870 Art & Cindy Strauss Vol#: 264

EMC 9871 Daniela Bajlo Vol#: 264

EMC 9872 Mario Ramirez Vol#: 264

EMC 9873 Mario Ramirez Vol#: 264

EMC 9874 Tim Vol#: 264

EMC 9875 Temfield@aol.com Vol#: 264

EMC 9876 Mr & Mrs Erik Jenson Vol#: 264

EMC 9877 John Rodenbarger Vol#: 264

EMC 9878 John Rodenbarger Vol#: 264

EMC 9879 John McGovern Vol#: 264

EMC 9880 John McGovern Vol#: 264

EMC 9881 Kim Marine-Okochi Vol#: 264

EMC 9882 Kim Marine-Okochi Vol#: 264

EMC 9883 Eric Brown Vol#: 264

EMC 9884 Number not used Vol#: 264

EMC 9885 Chris Negrin Vol#: 264

EMC 9886 Chris Negrin Vol#: 264

EMC 9887 Heather O'Donnell Vol#: 264

EMC 9888 Caryl F. Burnett Vol#: 264

EMC 9889 Christina Novela Vol#: 264

EMC 9890 Margaret W. Chapman Vol#: 264

EMC 9891 Helen Novela Vol#: 264

EMC 9892 Bernard Sacks Vol#: 264

EMC 9893 Sue Salas Vol#: 264

EMC 9894 Marri McKinnon-Hust Vol#: 264

EMC 9895 Merrill Cook Vol#: 264

EMC 9896 Robert Cohen Vol#: 264

EMC 9897 Mary Lighthall Vol#: 264

EMC 9898 Mary Lighthall Vol#: 264

EMC 9899 Suzanne Grill Vol#: 264

EMC 9900 Roy Fish Vol#: 264

EMC 9901 Roy Fish Vol#: 264

EMC 9902 Michelle Rump Vol#: 264

EMC 9903 Bernadette Kazmarski Vol#: 264

EMC 9904 Cindy Batton Vol#: 264

EMC 9905 Summer Farnese Vol#: 264

EMC 9906 Mary Quesnel Vol#: 264

EMC 9907 E. Albertson Vol#: 264

EMC 9908 E. Albertson Vol#: 264

EMC 9909 CJ Webber II Vol#: 264

EMC 9910 Peter Makus Vol#: 264

EMC 9911 Kathryn A. Hynes Vol#: 264

EMC 9912 Kathryn A. Hynes Vol#: 264

EMC 9913 Michael Toner Vol#: 264

EMC 9914 Wayne Messere Vol#: 264

EMC 9915 Sara Kohn Vol#: 264

EMC 9916 Sara Kohn Vol#: 264

EMC 9917 Patty Heffner Vol#: 264

EMC 9918 Kevin & Eileen Kelly Vol#: 264

EMC 9919 Margaret Leonard Vol#: 264

EMC 9920 Bob Sparks Vol#: 264

EMC 9921 Mary Ann John Vol#: 264

EMC 9922 Diane K. Stevenson Vol#: 264

EMC 9923 Marian Thompson Vol#: 264

EMC 9924 Marian Thompson Vol#: 264

EMC 9925 Nora Zablow Vol#: 264

EMC 9926 Nora Zablow Vol#: 264

EMC 9927 Alice Andrews Vol#: 264

EMC 9928 Ernest Lent Vol#: 264

EMC 9929 Number not used Vol#: 264

EMC 9930 Linda K. Kelly Vol#: 264

EMC 9931 Rani Silverberg Vol#: 264

EMC 9932 Agnes Harkay Vol#: 264

EMC 9933 Agnes Harkay Vol#: 264

EMC 9934 Mark Fernen Vol#: 264

EMC 9935 The Settells Vol#: 264

EMC 9936 Jim Mellen Vol#: 264

EMC 9937 Rose Berry Vol#: 264

EMC 9938 Stuart Henderson Vol#: 264

EMC 9939 Rachel Cohen Vol#: 264

EMC 9940 Rachel Cohen Vol#: 264

EMC 9941 Mike Martin Vol#: 264

EMC 9942 Sherry Wilson Vol#: 264

EMC 9943 Eileen Theimer Vol#: 264

EMC 9944 Susan Revak Vol#: 264

EMC 9945 Susan Revak Vol#: 264

EMC 9946 Leah Sargent Vol#: 264

EMC 9947 Lisa Stewart Vol#: 264

EMC 9948 Michelle Rump Vol#: 264

EMC 9949 Georgia Di Martino Colombo Vol#: 264

EMC 9950 Christina Betteys Vol#: 264

EMC 9951 Greg Diaz Vol#: 264

EMC 9952 Eliot Kaplan Vol#: 264

EMC 9953 Daniel Wilkinson Vol#: 264

EMC 9954 Romany Wood Vol#: 264

EMC 9955 Sandy Courtnage Vol#: 264

EMC 9956 Joanne Webb Vol#: 264

EMC 9957 Ryan Schmidt Vol#: 264

EMC 9958 Diane Vulcan Vol#: 264

EMC 9959 Organic Farming Research Foundation Vol#: 264

EMC 9960 Cynthia Jackson Vol#: 264

EMC 9961 Cynthia Jackson Vol#: 264

EMC 9962 Kate Garison Vol#: 264

EMC 9963 Daniel Pendleton Vol#: 264

EMC 9964 Sean Massey Vol#: 264

EMC 9965 Walter Epp Vol#: 264

EMC 9966 Dr. Michael Shepherd Clarage Vol#: 264

EMC 9967 Jessica Lewis Vol#: 264

EMC 9968 Jessica Lewis Vol#: 264

EMC 9969 Trina Burke Vol#: 264

EMC 9970 Dorothy Bosco Vol#: 264

EMC 9971 Therese Ciesinski Vol#: 264

EMC 9972 Tom & Gail Wiley Vol#: 264

EMC 9973 Densie Cox Vol#: 264

EMC 9974 Densie Cox Vol#: 264

EMC 9975 John Hettinger Vol#: 264

EMC 9976 John Hettinger Vol#: 264

EMC 9977 Demian R. Potter Vol#: 264

EMC 9978 Ellen Kamhi, Ph.D., R.N. Vol#: 264

EMC 9979 Edward McCarthy III & Shari McCarthy Vol#: 264

EMC 9980 Simone Craig Vol#: 264

EMC 9981 Margaret A. Manca Vol#: 264

EMC 9982 Jo Kirkpatrick Vol#: 264

EMC 9983 Jennifer Kauhane Vol#: 264

EMC 9984 Leslie Dorst Vol#: 264

EMC 9985 Melody Bougopoulos Vol#: 264

EMC 9986 Jodi Medlar Vol#: 264

EMC 9987 Jeb Bateman Vol#: 264

EMC 9988 Marie Claire Blanco Vol#: 264

EMC 9989 Margaret W. Chapman Vol#: 264

EMC 9990 Linda Alexander Vol#: 264

EMC 9991 Linda Alexander Vol#: 264

EMC 9992 Number not used Vol#: 264

EMC 9993 Linda E. Alexander Vol#: 264

EMC 9994 Jeremy Engel Vol#: 264

EMC 9995 Michael Blanks Vol#: 264

EMC 9996 James Rusk Vol#: 264

EMC 9997 Number not used Vol#: 264

EMC 9998 Number not used Vol#: 264

EMC 9999 Beth Siegelbaum Vol#: 264

EMC 10000 Beth Siegelbaum Vol#: 264

00P-0499 Review/Act on SKB '132 Form C & '423 Form A patent for NDA20

C 6 GlaxoSmithKline Corporation Vol#: 2

01D-0162 Using FDA-Approved Patient Labeling in Consumer-Directed

C 11 GSK, Glaxo Smith Kline (United Kingdom) Vol#: 1

01D-0202 Provisions of the FDA Modernization Act of 1997

C 3 Terumo Medical Corporation Vol#: 1

01D-0224 Mass Spectrometry for Confirmation of Identity of Animal Dru

M 1 HF-26 Vol#: 1

01H-0065 Civil Money Penalty for First Check Home Drug Test Decives

MO 7 Worldwide Medical Corporation Vol#: 1

01N-0197 Treatment of Ankylosing Spondylitis and Related Disorders

C 4 Boston University School of Medicine Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 147 Patrick Ray Vol#: 9

C 148 Gulsen Calik Vol#: 9

01P-0248 Clarify Issues Relating to Patent Listings in "Orange Book"

C 1 GlaxoSmithKline Corporation Vol#: 1

C 2 Apotex Inc Vol#: 1

01P-0323 Not rely on non-public filings to approve an innovator NDA;

ACK 1 HFA-305 Vol#: 1

CP 1 Pfizer Inc. & Pharmacia Corp. Vol#: 1

01V-0324 Laser Light Show Mobolazer ML8-20G,Ml8-50RG,ML10-250,

ACK 1 HFA-305 Vol#: 1

VAR 1 Midwest Sound & Light Vol#: 1

01V-0325 laser light show Mobolazer ML8.50RG

ACK 1 HFA-305 Vol#: 1

VAR 1 Red Oak Lanes Vol#: 1

01V-0326 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Club Tango Vol#: 1

01V-0327

ACK 1 HFA-305 Vol#: 1

VAR 1 Star Light & Magic Vol#: 1