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 June 3, 2002

TABLE OF CONTENTS

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01N-0322 Institutional Review Boards *
01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits *
01P-0533 Determine whether Rubrmin PC 1mg/mL & 10-ml has been volunta *
01P-0542 ANDA suitability for Diazepam Injection Auto-Injector *
02D-0094 IND Exemptions for Studies of Lawfully Marketed Cancer Drugs *
02D-0095 Exposure-Response Relaionship;Study Design,Data Analysis *
02N-0115 Risk Management of Prescription Drugs; Public Hearing *
02N-0209 Governing First Amendment Case Law *
02P-0191 Request for immediate final approval of tramadol Hydrochlori *
02P-0256 Determine if ANDA 76-122 is Entitled to 180 Days Exclusivity *

98N-0337 Over the counter human drugs labeling requirements

APP 41 L N K International, Inc. Vol#: 8

99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O

EMC 41 David Wallinga, M.D. Vol#: 1

EMC 42 Paul Barriere Vol#: 1

EMC 43 David N. Brown Vol#: 1

EMC 44 Allison McNabb Vol#: 1

EMC 45 Diane Rogers Vol#: 1

EMC 46 Nancy Mills Vol#: 1

EMC 47 Michaela Vancliff Vol#: 1

EMC 48 Alice Yang Vol#: 1

EMC 49 Ms. Diana Austin Vol#: 1

EMC 50 Shawn Casey Vol#: 1

EMC 51 Jo-Ann Murphy Vol#: 1

EMC 52 MHigdon Vol#: 1

EMC 53 Jon Wade Shumway Vol#: 1

EMC 54 Patty Kirwen Vol#: 1

EMC 55 number not used Vol#: 1

EMC 56 Beth Rainey Vol#: 1

EMC 57 Kevin P. Silacci Vol#: 1

EMC 58 Jennie Hoover Vol#: 1

EMC 59 Caron Byl Vol#: 1

EMC 60 Lisha Doucet Vol#: 1

EMC 61 Jacquelyn Forseth Vol#: 1

EMC 62 Francesca Funk Vol#: 1

EMC 63 Jimmy Lolovic Vol#: 1

00D-1542 Electronic Signatures: Time Stamps

C 1 Aventis Pasteur Vol#: 1

01N-0322 Institutional Review Boards

C 13 Merck & Co., Inc. Vol#: 1

C 14 AstraZeneca Vol#: 1

C 15 Barbara J. Evans, PhD., J.D. Vol#: 1

EC 4 Baylor College of Medicine Vol#: 1

01N-0548 Guidelines for Voluntary Nutrition Labeling of Raw Fruits

C 3 American Frozen Food institute (AFFI) Vol#: 1

SUP 1 Ketchum Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

EC 8 Dr. Robert Shimp Vol#: 141

01P-0533 Determine whether Rubrmin PC 1mg/mL & 10-ml has been volunta

LET 1 HFD-1 to PharmaForce, Inc. Vol#: 1

01P-0542 ANDA suitability for Diazepam Injection Auto-Injector

LET 1 HFD-1 to Meridian Medical Technologies Vol#: 1

02D-0094 IND Exemptions for Studies of Lawfully Marketed Cancer Drugs

EC 1 MD Anderson Cancer Center Vol#: 1

02D-0095 Exposure-Response Relaionship;Study Design,Data Analysis

C 2 Cognigen Corporation Vol#: 1

C 3 Bristol-Myers Squibb Vol#: 1

C 4 Bayer Vol#: 1

02F-0181 Use of cetylpyridinium chloride as an antimicrobial

EA 1 BACKGROUND MATERIAL Vol#: 1

02N-0047 Development of Antibiotics for Resistant Pathogens

EC 2 Mr. Robert Hamrick Vol#: 1

02N-0115 Risk Management of Prescription Drugs; Public Hearing

EC 4 Revolution inc. Vol#: 1

EC 5 Number Not Used Vol#: 1

02N-0131 Generic FDA Rapid Response Surveys;Information Collection Ac

EC 1 None Vol#: 1

02N-0209 Governing First Amendment Case Law

C 1 National Organization for Rare Disorders Vol#: 1

EC 3 Chester County Research Center Vol#: 1

EC 4 none Vol#: 1

EC 5 Mrs. Myrna Mitchell Vol#: 1

EC 6 Veterans Administration Vol#: 1

EC 7 Peak Management Consulting and Training Vol#: 1

EC 8 Ms. Melissa Yorks Vol#: 1

EC 9 Mrs. Arline Brecher Vol#: 1

EC 10 Mr. Charles Marcus Vol#: 1

EC 11 Mr. Thomas Kniest Vol#: 1

EC 12 Golden Gate University Vol#: 1

EC 13 Retired Vol#: 1

EC 14 Well Of Living Water Christian Fellowshi Vol#: 1

EC 15 Mr. GENE WRIGHT Vol#: 1

EC 16 Health Horizons Inc. Vol#: 1

EC 17 Mr. Jonathan Sisson Vol#: 1

EC 18 Ms. Beverly Nadelman Vol#: 1

EC 19 Retired Vol#: 1

EC 20 Mr. Fred Hornblower Vol#: 1

EC 21 Mr. William Hartman Vol#: 1

EC 22 Ms. Virginia Riker Vol#: 1

EC 23 Mr. DeWayne Williams Vol#: 1

EC 24 Ms. Lila Berman Vol#: 1

EC 25 Mr. Hanns Derke Vol#: 1

EC 26 Dr. Richard Ranheim Vol#: 1

EC 27 Ms. Margaret Klugherz Vol#: 1

EC 28 Mr. Jon Barron Vol#: 1

EC 29 Mr. Hank h Vol#: 1

EC 30 Mr. Scott Maley Vol#: 1

EC 31 Mr. Don Maiello Vol#: 1

EC 32 Mr. Harold Hennes Vol#: 1

EC 33 Mr. Robert Lundgren Vol#: 1

EC 34 Mr. George Mesmer Vol#: 1

EC 35 Mr. robeert parker Vol#: 1

EC 36 Dr. James Zeller Vol#: 1

EC 37 U.S.A. Citizen Vol#: 1

EC 38 Mr. Eugene Mouncer Vol#: 1

EC 39 Mr. E Engel Vol#: 1

EC 40 Ms. susan Vandegrift Vol#: 1

EC 41 Mr. Leo van Olphen Vol#: 1

02P-0191 Request for immediate final approval of tramadol Hydrochlori

RC 2 Johnson & Johnson Pharm. Research et al Vol#: 1

02P-0256 Determine if ANDA 76-122 is Entitled to 180 Days Exclusivity

ACK 1 HFA-305 Vol#: 1

CP 1 Mylan Pharmaceuticals, Inc. Vol#: 1