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| Dockets Entered
On May 10, 2007
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| Docket #
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| Title
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| 2004E-0427
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| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
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| 2005E-0234
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| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
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| 2006E-0005
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
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| 2006E-0006
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| 2006E-0345
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
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| 2007D-0173
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| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
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| 1995S-0316
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| 75-Day Premarket Notifications for New Dietary Ingredients
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| RPT 377
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| Alltracel Pharma Ltd
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| Vol #:
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| 298
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| RPT 378
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| Archer Daniels Midland Company
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| Vol #:
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| 299
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| C 1022
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| C. Thomas
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| Vol #:
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| 68
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| EC 7946
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| Ms. Robin Migalla
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| Vol #:
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| 65
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| EC 7947
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| Ms. Jeannie Ben-Hain
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| Vol #:
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| 65
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| EC 7948
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| Ms. Amy Iager
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| Vol #:
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| 65
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| EC 7949
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| Ms. Joanna Long
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| Vol #:
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| 65
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| EC 7950
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| Mrs. Lisa D'Antonio
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| Vol #:
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| 65
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| EC 7951
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| Food Animal Concerns Trust
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| Vol #:
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| 65
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| EC 7952
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| Mrs. Khanh Van Oss
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| Vol #:
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| 65
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| EC 7953
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| Ms. Jacqueline Guizado de Nathan
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| Vol #:
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| 65
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| EC 7954
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| Ms. Dee Wilson
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| Vol #:
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| 65
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| EC 7955
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| Mrs. Bari Allen
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| Vol #:
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| 65
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| EC 7956
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| Readington Farms Inc.
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| Vol #:
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| 65
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| EC 7957
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| Ms. Paula Zammit
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| Vol #:
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| 65
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| EC 7958
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| Miss. Andrea Bray
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| Vol #:
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| 65
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| EC 7959
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| Mrs. rose shulman
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| Vol #:
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| 65
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| EC 7960
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| Ms. Laura Donohue
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| Vol #:
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| 65
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| EC 7961
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| Mrs. Ryana Dykes
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| Vol #:
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| 65
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| EC 7962
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| Turkey Hill Dairy, Inc.
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| Vol #:
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| 65
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| EC 7963
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| Biocampo S.A. de C.V.
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| Vol #:
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| 65
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| EC 7964
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| Ms. Margaret Sloan
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| Vol #:
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| 65
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| EC 7965
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| Publix Super Markets, Inc.
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| Vol #:
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| 65
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| EC 7966
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| Ms. Jackie Schierloh
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| Vol #:
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| 65
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| EC 7967
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| Mr. Bradley Bowen
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| Vol #:
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| 65
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| EC 7968
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| Ms. Daniela Martinez
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| Vol #:
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| 65
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| EC 7969
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| Miss. Jennifer Masiello
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| Vol #:
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| 65
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| EC 7970
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| Mrs. Katie Anne Cates
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| Vol #:
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| 65
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| EC 7971
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| Mrs. Jamie Gould
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| Vol #:
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| 65
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| EC 7972
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| Dr. Karen Scott
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| Vol #:
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| 65
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| EC 7973
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| Mrs. Valorie Scott
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| Vol #:
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| 65
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| EC 7974
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| Mr. James Moore
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| Vol #:
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| 65
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| EC 7975
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| Mr. Russ Lang
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| Vol #:
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| 65
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| EC 7976
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| Ms. lydia perry
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| Vol #:
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| 65
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| EC 7977
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| Ms. M Moran
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| Vol #:
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| 65
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| EC 7978
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| Mr. Andrew McKleroy
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| Vol #:
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| 65
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| EC 7979
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| Mrs. Charity Blakely
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| Vol #:
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| 65
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| EC 7980
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| Mr. Steve Allen
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| Vol #:
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| 65
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| EC 7981
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| Mrs. Lea Bronstein
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| Vol #:
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| 65
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| EC 7982
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| Mr. Maxwell Elia
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| Vol #:
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| 65
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| EC 7983
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| Mr. Stephen Pew
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| Vol #:
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| 65
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| EC 7984
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| Mrs. Kamala Alpert
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| Vol #:
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| 65
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| EC 7985
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| Mrs. Tami Maxwell
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| Vol #:
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| 65
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| EC 7986
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| Mr. Justin Lovelace
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| Vol #:
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| 65
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| EC 7987
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| Ms. Lauren Raece
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| Vol #:
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| 65
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| EC 7988
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| Delpino Design
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| Vol #:
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| 65
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| EC 7989
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| Ms. anita bueno
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| Vol #:
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| 65
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| EC 7990
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| Ms. Marsha Vilt
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| Vol #:
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| 65
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| EC 7991
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| Mr. Anthony Vilt
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| Vol #:
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| 65
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| EC 7992
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| Mr. Justin Kantor
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| Vol #:
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| 65
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| EC 7993
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| Leprino Foods Company
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| Vol #:
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| 65
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| EC 7994
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| U.S. Dairy Export Council
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| Vol #:
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| 65
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| EC 7995
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| Ms. Carrie Eichelberger
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| Vol #:
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| 65
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| EC 7996
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| Yorkshire Animal Protection and Concerns
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| Vol #:
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| 65
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| EC 7997
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| Mrs. Debra Ricci
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| Vol #:
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| 65
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| EC 7998
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| Mrs. Carlene McLaughlin
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| Vol #:
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| 65
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| EC 7999
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| Ms. Lesley Sloan
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| Vol #:
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| 65
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| EC 8000
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| Yorkshire ANIMAL Protection and Concerns
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| Vol #:
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| 65
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| EC 8001
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| Mrs. Bridget Bonham
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| Vol #:
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| 65
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| EC 8002
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| Dr. Lori Ugolik
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| Vol #:
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| 65
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| EC 8003
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| Mrs. Melissa Guinn
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| Vol #:
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| 65
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| EC 8004
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| Mrs. Terrie Williams
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| Vol #:
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| 65
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| EC 8005
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| National Meat Association
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| Vol #:
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| 65
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| EC 8006
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| Miss. Elena Pintilie
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| Vol #:
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| 65
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| EC 8007
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| Ms. MARY LEARN
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| Vol #:
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| 65
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| EC 8008
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| Ms. Dee Banks
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| Vol #:
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| 65
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| EC 8009
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| Mrs. Karen Stillwell
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| Vol #:
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| 65
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| EC 8010
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| Ms. Anne OBarsky
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| Vol #:
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| 65
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| EC 8011
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| Ms. Alys Granados
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| Vol #:
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| 65
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| EC 8012
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| Ms. Diane Zeutas-Broer
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| Vol #:
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| 65
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| EC 8013
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| Dr. hiroshi suzuki
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| Vol #:
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| 65
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| EC 8014
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| Miss. Susan Morrison
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| Vol #:
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| 65
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| EC 8015
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| Ms. Jessica Cresseveur
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| Vol #:
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| 65
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| EC 8016
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| Dr. d muraco
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| Vol #:
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| 65
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| EC 8017
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| Mrs. Rose Ogorzaly
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| Vol #:
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| 65
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| EC 8018
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| Foremost Farms USA Cooperative
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| Vol #:
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| 65
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| EC 8019
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| Mrs. Juliana Marques
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| Vol #:
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| 65
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| EC 8020
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| Dr. Barry Hammer
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| Vol #:
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| 65
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| EC 8021
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| Mrs. Anthony Montapert
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| Vol #:
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| 65
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| EC 8022
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| Ms. ds evans
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| Vol #:
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| 65
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| EC 8023
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| Mrs. Donna Young
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| Vol #:
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| 65
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| EC 8024
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| Miss. Oyku Akcol
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| Vol #:
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| 65
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| EC 8025
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| Miss. stephanie Rioux
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| Vol #:
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| 65
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| EC 8026
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| na
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| Vol #:
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| 65
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| EC 8027
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| Ms. Vira Confectioner
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| Vol #:
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| 65
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| EC 8028
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| Ms. Mary Paz
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| Vol #:
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| 65
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| EC 8029
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| Mr. Armando Paz
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| Vol #:
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| 65
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| EC 8030
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| Ms. Maria Paz
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| Vol #:
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| 65
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| EC 8031
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| Ms. Joann Paz
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| Vol #:
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| 65
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| EC 8032
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| Mr. Durance Cordoba
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| Vol #:
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| 65
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| EC 8033
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| Ms. Felicita Roman
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| Vol #:
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| 65
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| EC 8034
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| Ms. Viviana Rodriguez
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| Vol #:
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| 65
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| EC 8035
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| Mr. Antonio Rodriquez
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| Vol #:
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| 65
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| EC 8036
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| Ms. Suzanne Schmitt
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| Vol #:
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| 65
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| EC 8037
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| Ms. Doreen Forbes
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| Vol #:
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| 65
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| EC 8038
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| Ms. Ana Verastegui
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| Vol #:
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| 65
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| EC 8039
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| Mrs. Scarlett Porter
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| Vol #:
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| 65
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| EC 8040
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| Mrs. Marjorie Hass
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| Vol #:
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| 65
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| EC 8041
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| Ms. Nancy Scott
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| Vol #:
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| 65
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| EC 8042
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| Miss. Dilini Meewewa
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| Vol #:
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| 65
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| EC 8043
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| Ms. Danube Jacobs
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| Vol #:
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| 65
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| EC 8044
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| Mr. Christian Lindberg
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| Vol #:
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| 65
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| EC 8045
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| Ms. Lynne Brady
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| Vol #:
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| 65
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| EC 8046
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| Deerbrook Guinea Pig
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| Vol #:
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| 65
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| 2004D-0440
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| Guidance for Industry on Computerized Systems Used in Clinical Trials
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| GDL 2
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| GUIDANCE
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| Vol #:
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| 1
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| NAD 2
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| FDA
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| Vol #:
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| 1
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| 2004E-0427
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| Patent Extension for Ketek (telithromycin), U.S. Patent No. 5,635,485
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2005E-0234
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| Patent Extension Application for Macugen (pegaptanib sodium), U.S. Patent No. 6,051,698
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| LET 5
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0005
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,001,876
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0006
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| Patent Extension Application for Lyrica (pregabalin), U.S. Patent No. 6,197,819
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| LET 4
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| 2006E-0023
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 and NDA 21-754), U.S. Patent No. 6,107,458
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| LET 8
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 2
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| 2006E-0345
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| Patent Extension Application for Mycamine (micafungin sodium) (NDA 21-506 & NDA 21-754), U.S. Patent No. 6,265,536
|
| |
|
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| LET 6
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| FDA/CDER to the U.S. Patent and Trademark Office
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| Vol #:
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| 1
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| |
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| 2007D-0173
|
| Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
|
| |
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| GDL 1
|
| GUIDANCE
|
| Vol #:
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| 1
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| |
|
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| NAD 1
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| FDA
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| Vol #:
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| 1
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