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 December 20, 2001

TABLE OF CONTENTS

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[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]
 
98N-1038 Irradiation in the production, processing, &handling of food *
00N-1665 Consumer Roundtable; Notice of Meeting *
01D-0361 Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil *
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01P-0139 Suitability petition to file ANADA for prednisolone oral pas *
01P-0140 Suitability petition to file ANADA for Cefadroxil Oral Paste *
01P-0141 Suitability petition to file ANADA for Amoxicillin oral past *
01P-0320 Establish Format Standards for Ingredient Labels on Food Pro *
01P-0323 Not rely on non-public filings to approve an innovator NDA; *
01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II *
93D-0139 Stability Testing of Biotechnological/Biological Products

EC 1 Number Not Used Vol#: 2

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

EMC 497 Robert Fort Vol#: 180

EMC 498 Julie Pihl Vol#: 180

EMC 499 Christopher G. Toon Vol#: 180

EMC 500 Colleen Hartford Vol#: 180

EMC 501 Maria Weber Vol#: 180

EMC 502 Denis Markian Wichar Vol#: 180

EMC 503 Pete & Rebecca Kallinger Vol#: 180

EMC 504 Dorine Barranco Vol#: 180

EMC 505 Justin Griffin Vol#: 180

EMC 506 Rose Mari Vol#: 180

EMC 507 Joe Gardner Vol#: 180

EMC 508 Paul Moss Vol#: 180

EMC 509 Gaylon Harden Vol#: 180

EMC 510 Mary Halligan Vol#: 180

EMC 511 John F. Kohler Vol#: 180

EMC 512 David L. Larson Vol#: 180

EMC 513 Caitlin Daniel Vol#: 180

EMC 514 Barbara Veldhuizen Vol#: 180

EMC 515 Jocelyn Harimon Vol#: 180

EMC 516 William N. Howald Vol#: 180

EMC 517 Ronald Galbavy Vol#: 180

EMC 518 Philip H. Coe Vol#: 180

EMC 519 C. Weiss Vol#: 180

EMC 520 Jeanne Marion Vol#: 180

EMC 521 Leland David Gibbs Vol#: 180

EMC 522 Katherine Freund Vol#: 180

00D-1538 Electronic Records; Electronic Signatures, Validation

C 6 Merck & Co., Inc. Vol#: 5

C 7 F. Hoffmann-La Roche Ltd. (Basel) Vol#: 5

C 8 AdvaMed (Advanced Med. Technology Assn.) Vol#: 5

00D-1543 Electronic Signatures: Glossary of Terms

C 4 AdvaMed (Advanced Med. Technology Assn.) Vol#: 5

C 5 Pharmacia Corp. Vol#: 5

EC 3 Dr. Stephen Connolly Vol#: 6

00N-1665 Consumer Roundtable; Notice of Meeting

EC 29 Ms. Rose Large Vol#: 1

01D-0361 Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil

C 5 GlaxoSmithKline Vol#: 1

01D-0475 Providing Regulatory Submissions in Electronic Format-ANDA's

EC 2 Number Not Used Vol#: 1

01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm

EC 3 University of Illinois Vol#: 1

01N-0397 Transportation Safety & Potentially Sedating or Impairing

EC 7 WellPoint Health Networks Vol#: 2

01N-0458 Fast Track Drug Development Programs Designation,Development

EC 3 Number Not Used Vol#: 1

EC 4 Number Not Used Vol#: 1

01P-0139 Suitability petition to file ANADA for prednisolone oral pas

PAV 1 HFV-100 to Vetoquinol N.-A., Inc (Canad Vol#: 1

01P-0140 Suitability petition to file ANADA for Cefadroxil Oral Paste

PAV 1 HFV-100 to Vetoquinol N.-A., Inc (Canad Vol#: 1

01P-0141 Suitability petition to file ANADA for Amoxicillin oral past

PAV 1 HFV-100 to Vetoquinol N.-A., Inc (Canad Vol#: 1

01P-0320 Establish Format Standards for Ingredient Labels on Food Pro

C 110 Joseph Martino Vol#: 5

C 111 Lucy Hill Vol#: 5

C 112 Mary Cone Vol#: 5

C 113 Valerie Peebles Vol#: 5

C 114 Sandra Gunderson Vol#: 5

C 115 Helen Nelson Vol#: 5

C 116 Bernadette O'Connor Vol#: 5

C 117 Shirley Montgomery Vol#: 5

C 118 Kimberly A. Mudar Vol#: 5

C 119 Jean P. Patterson Vol#: 5

C 120 Nat Hendricks Vol#: 5

C 121 J. Golf and T. Trusty Vol#: 5

C 122 Hilary Holm Vol#: 5

C 123 Ray and Lella Conatser Vol#: 5

C 124 Barbara R. Kalnins Vol#: 5

C 125 Mrs. Karen E. Furgerson Vol#: 5

C 126 Mary L. Owen Vol#: 5

C 127 Mr. Paul Griffith Vol#: 5

C 128 Marilyn Hartig Vol#: 5

C 129 Jeanne B. Pepper Vol#: 5

C 130 Hildegarde Hannum Vol#: 5

C 131 Andrew and Carol Warner Vol#: 5

C 132 Bradford Johnson Vol#: 5

C 133 Burton F. Kline Vol#: 5

C 134 Megan Thomas Vol#: 5

C 135 Linn Gerasimo Vol#: 5

C 136 Pat Smrekar Vol#: 5

C 137 Ms. Margaret H. Shinaver Vol#: 5

C 138 Mrs. John Bubon Vol#: 5

C 139 James W. Gilmon Vol#: 5

C 140 Ann Thomas Vol#: 5

C 141 Lee Brown Vol#: 5

C 142 Myron M. Pisetsky, M.D. Vol#: 5

C 143 Jean Massnick Vol#: 6

C 144 Virginia Parn Vol#: 6

C 145 Gayna Uransky Vol#: 6

C 146 Ms. Olga Viade Vol#: 6

C 147 Frances Howell Vol#: 6

C 148 James DeSena Vol#: 6

C 149 Pat Goodman Vol#: 6

C 150 Irv and Renee Barger Vol#: 6

C 151 Cipah and Abe Shapiro Vol#: 6

C 152 Wendy Suit Vol#: 6

C 153 Ms. Constance J. Gibson Vol#: 6

C 154 Arlene Sachs Vol#: 6

C 155 Deborah H. Powers Vol#: 6

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

C 2 Amgen Inc. Vol#: 1

01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II

C 6 Janet Tier Vol#: 1

C 7 C. R. Vol#: 1