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 November 28, 2001

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
01D-0489 Establishment & Operation of Clinical Trial Monitoring Comm *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01N-0450 Prescription Drug User Fee Act (PDUFA) *
01N-0458 Fast Track Drug Development Programs Designation,Development *
01N-0464 Vaccine Adverse Event Reporting System *
01Q-0313 Health Claim Petition for Soluble Fiber from Oatrim *
75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

CP 10 C.T.F.A Vol#: 114

77N-0085 Saccharin and Its Salts

CA 17036 Opinion Ballot Vol#: 392

CA 18877 Number Not Used Vol#: 413

CA 18889 James R. Schueler Vol#: 413

CA 19037 Number Not Used Vol#: 414

98N-0337 Over the counter human drugs labeling requirements

APP 33 McNeil Consumer Healthcare Vol#: 8

APP 34 McNeil Consumer Healthcare Vol#: 8

APP 35 McNeil Consumer Healthcare Vol#: 8

APP 36 McNeil Consumer Healthcare Vol#: 8

APP 37 McNeil Consumer Healthcare Vol#: 8

98N-1215 Foreign Establishment Registration and Listing

NFR 1 Vol#: 2

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

C 5325 Ms. Terry L. Kristensen Vol#: 190

C 5326 Wendy & Ron Byland Vol#: 190

C 5327 H. Knost, RN Vol#: 190

C 5328 Reverend Sheilah Renaud Vol#: 190

C 5329 Dr. Ronald J. Baumgarten Vol#: 190

C 5330 Marianne Misnik Vol#: 190

C 5331 Mr. & Mrs. Daniel P. Rathmann Vol#: 190

C 5332 Morike Feldenkrain Vol#: 190

C 5333 Shawn Calhoon Vol#: 190

C 5334 Ali Ebrahimzadeh Vol#: 190

C 5335 Laura C. Redi Vol#: 190

C 5336 Billy Prusinowski Vol#: 190

C 5337 Rosamund Downing Vol#: 190

C 5338 Ms. Elizabeth Gingery Vol#: 190

C 5339 Sally Hopkins Vol#: 190

C 5340 Laurel McSpadden Vol#: 190

C 5341 Jayne M. Peyton Vol#: 190

C 5342 Mr. & Mrs. W. B. Woolley Vol#: 190

C 5343 Lisa T. Skardinski Vol#: 190

C 5344 Janie Peto Vol#: 190

C 5345 Peggy Philbrook Vol#: 190

C 5346 Joseph Lener Vol#: 190

C 5347 Grace E. Naccarato Vol#: 190

C 5348 Dolores E. de Fore Vol#: 190

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9148 Jessica Newens Vol#: 401

C 9149 Maudi Neconian & Ellinor Shelton Witt Vol#: 401

C 9150 L. Gladchild Vol#: 401

C 9151 Cynthia Scott Vol#: 401

C 9152 Jerry Reese Vol#: 401

C 9153 Wayne J. Behrle Vol#: 401

C 9154 Nellie Ingram Vol#: 401

C 9155 Scott Gilbert Vol#: 401

C 9156 Lawrence Lejfer Vol#: 401

C 9157 Philip Blanchfield Vol#: 401

C 9158 Kathryn Parry Vol#: 401

C 9159 Wesley Strong Vol#: 401

C 9160 Kevin M. Beahan Vol#: 401

C 9161 Joshua Park Vol#: 401

C 9162 Tim Kolsar Vol#: 401

C 9163 Donna Minster Vol#: 401

C 9164 Grace Jeon Vol#: 401

C 9165 Dawn Hoffman Vol#: 401

C 9166 Ian Arthur Vol#: 401

C 9167 Michael Smith Vol#: 401

C 9168 Mitch Harris & Erica Siegel Vol#: 401

C 9169 Jody Wolfe Vol#: 401

C 9170 Judy Ambrose Vol#: 401

C 9171 Morgan Broderick Vol#: 401

C 9172 Jennifer Dorward Vol#: 401

C 9173 Kevin Uehlinger Vol#: 401

C 9174 Valerie Graber Vol#: 401

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

EC 1 Rand Vol#: 1

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

CH 34 Minnesota Department of Agriculture Vol#: 5

CH 35 Ohio Department of Agriculture Vol#: 5

CH 36 State of California Vol#: 5

CH 37 Pennsylvania Department of Agriculture Vol#: 5

CH 38 Fats & Proteins Research Foundation,Inc. Vol#: 5

01N-0450 Prescription Drug User Fee Act (PDUFA)

EAPE21 Number Not Used Vol#: 1

EAPE22 none Vol#: 1

EAPE23 Public Strategies, Inc. Vol#: 1

EAPE24 ViCro Vol#: 1

EAPE25 CDER Public Affairs Vol#: 1

EAPE26 National Coalition for Cancer Research Vol#: 1

EAPE27 National Medical Association Vol#: 1

EAPE28 S-Plus Vol#: 1

EAPE29 Colorectal Cancer Network Vol#: 1

EAPE30 Generic Pharmaceutical Association Vol#: 1

EAPE31 AIDS Action Vol#: 1

EAPE32 Tufts Center for the Study of Drug Devel Vol#: 1

EAPE33 Epilepsy Foundation Vol#: 1

EAPE34 EMD Pharmaceuticals, Inc. Vol#: 1

EAPE35 Nat. Ctr. for Policy Research for Women Vol#: 1

EAPE36 EpiGenesis Pharmaceuticals Vol#: 1

EAPE37 FDA/OC/OCCR/OPA Vol#: 1

EAPE38 Food and Drug Administration Vol#: 1

EAPE39 Bergner,Bockorny,Castagnetti, Hawkins, & Vol#: 1

EAPE40 American Pharmaceutical Association Vol#: 1

EAPE41 Office of Management and Budget Vol#: 1

EAPE42 CBER/FDA Vol#: 1

EAPE43 OMS/OC/FDA Vol#: 1

EAPE44 Lupus Foundation of America Vol#: 1

EAPE45 AstraZeneca LP Vol#: 1

EAPE46 McNeil Consumer and Specialty Pharmaceut Vol#: 1

EAPE47 FDA Office of Orphan Products Developmen Vol#: 1

EAPE48 CDER/Office of Compliance Vol#: 1

EAPE49 Pharmacyclics, Inc. Vol#: 1

EAPE50 Abbott Laboratories Vol#: 1

EC 2 NHL-info (lymphoma list server) Vol#: 1

EC 3 NHL-info (Lymphoma support) Vol#: 1

EC 4 NHL-info (lymphoma support and informati Vol#: 1

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

EC 2 Stratton Research Vol#: 1

01N-0464 Vaccine Adverse Event Reporting System

EC 1 Wake Forest University School of Medicin Vol#: 1

EC 2 DHHS/CDC/NIP/IDS/POB Vol#: 1

01Q-0313 Health Claim Petition for Soluble Fiber from Oatrim

SUP 1 Rhodia Inc & Quaker Oats Company Vol#: 4