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DOCKETS ENTERED on July 16, 2002

TABLE OF CONTENTS

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01P-0323 Not rely on non-public filings to approve an innovator NDA; *
02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin *
02N-0204 Bar Code Label Requirements for human drug products *
02P-0177 Health Claim: D-tagatose and Noncariogenicity *
02P-0317 Recall Aspartame as a Neurotoxic Drug *

77N-0231 PENICILLIN IN ANIMAL FEEDS

C 24 Number Not Used Vol#: 1

80N-0042 Anticaries Drug Products for OTC Human Use

C 112 Consumer Healthcare Products Assn (CHPA) Vol#: 36

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9805 Rosa E. Venegas Vol#: 570

00E-1348 Patent Extension PROTONIX, No. 4,758,579

N 1 Vol#: 1

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

C 11 Lynda Gilgun Vol#: 1

01E-0366 Patent Term Extension Application, PEG-Intron No. 5,951,974

N 1 Vol#: 1

01N-0067 Reclassification of Dental Mercury

C 21 Marilynn Carter Vol#: 3

C 22 Ann Clifton Vol#: 3

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

C 4 Bristol-Myers Squibb Co. Vol#: 1

02E-0019 Patent Term Application for Axert No. 5,565,447

N 1 Vol#: 1

02N-0070 Regulations for In Vivo radiopharmaceuticals

N 2 Vol#: 1

02N-0152 Obtain Timely Pediatric Studies & Adequate Pediatric Labelin

C 121 Kathryn M. Edwards, M.D. Vol#: 3

C 122 Thomas J. Martin, M.D. Vol#: 3

C 123 Richard M. Lampe, M.D. Vol#: 3

C 124 Charles J. Barone, II, M.D. Vol#: 3

C 125 Terence S. Dermody Vol#: 3

C 126 George J. Dover, M.D. Vol#: 3

C 127 Stacey Epstein, M.D. FAAP Vol#: 3

C 128 Judy Lew, M.D. Vol#: 3

C 129 Cary P. Cavender, M.D. Vol#: 3

C 130 Michelle Amaya, M.D. MPH Vol#: 3

C 131 Ruth A. Lawrence, M.D. Vol#: 3

C 132 John Kulig, M.D. MPH Vol#: 3

C 133 Edwin N. Forman, M.D. Vol#: 3

C 134 Child & Adolescent Bipolar Foundation Vol#: 3

C 135 Robert D. Christensen, M.D. Vol#: 3

C 136 Terrence L. Stull, M.D. Vol#: 3

C 137 Mary C. Dinauer, M.D., PhD Vol#: 3

C 138 Carden Johnston, MD, FAAP, FACEP, FRCP Vol#: 3

C 139 Anothny F. Phillips, M.D., FAAP Vol#: 3

02N-0204 Bar Code Label Requirements for human drug products

C 3 McKesson Corporation Vol#: 1

EMC 3 Brian J. Henry Vol#: 1

EMC 4 Cygnus, Inc. Vol#: 1

EMC 5 John Sandusky Vol#: 1

EMC 6 AIM, Inc. Vol#: 1

EMC 7 AABB, American Assn. of Blood Banks Vol#: 1

EMC 8 Johns Hopkins Hospital Vol#: 1

EMC 9 USP Ctr for the Advancement of Patient S Vol#: 1

EMC 10 Healthcare Leadership Council Vol#: 1

EMC 11 Larry Paul Vol#: 1

EMC 12 HIDA, Health Industry Distributors Assn. Vol#: 1

EMC 13 CHPA, Consumer Healthcare Prods. Assn. Vol#: 1

EMC 14 Returns Online, Inc. Vol#: 1

EMC 15 McKesson Corp. Vol#: 1

EMC 16 University of Illinois at Chicago Vol#: 1

EMC 17 AIS, Automatic Identification Systems Vol#: 1

EMC 18 Omnicell, Inc. Vol#: 1

EMC 19 AIS, Automatic Identification Systems Vol#: 1

02P-0166 Print clear, legible & intelligible product expiration date

C 1 Honorable Barbara Lee (CI) Vol#: 1

02P-0177 Health Claim: D-tagatose and Noncariogenicity

LET 2 Arla Foods Ingredients amba (Arla) Vol#: 1

02P-0317 Recall Aspartame as a Neurotoxic Drug

ACK 1 HFA-305 Vol#: 1

CP 1 Mission Possible International Vol#: 1

02V-0318 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Laser Image Vol#: 1