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 30, 2001

TABLE OF CONTENTS

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93N-0371 Prescription Drug Product; Medication Guide Requirements *
99P-5332 Amend limit Hydrogenated & partially Hydrogenated Menhaden O *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00N-1525 Debarment of Richard Elliott Humphreys;Notice of Opportunity *
00P-1077 Amend Current Reg Banning Sale of Small Turtles *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0361 Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil *
01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA *
01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II *
01P-0542 ANDA suitability for Diazepam Injection Auto-Injector *
77N-0085 Saccharin and Its Salts

CA 19818 Number not used Vol#:

CA 19879 James A. Hallan Vol#: 423

CA 20152 Number Not Used Vol#: 426

CA 20368 Number not used Vol#:

CA 20402 M. Gibson Vol#: 429

92S-0251 Electronic Submissions; Establishment of Public Docket

M 15 CDER Postmarketing Espedited and Periodc Vol#: 1

M 16 CDER Withdraws M15 Vol#: 1

93N-0371 Prescription Drug Product; Medication Guide Requirements

EMC 1 Gail Gantt, R.N. Vol#: 14

98N-0337 Over the counter human drugs labeling requirements

APP 38 Novex Pharma Vol#: 8

APP 39 Novex Pharma Vol#: 8

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

SUP 2 National Fish Meal & Oil Assn Vol#: 1

00D-1538 Electronic Records; Electronic Signatures, Validation

C 2 Invivodata, Inc. Vol#: 5

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9589 Jessica Newens Vol#: 476

C 9590 Maudi M. Newman Vol#: 476

C 9591 L. Gladchild Vol#: 476

C 9592 Cynthia Scott Vol#: 476

C 9593 Jetty Reese Vol#: 476

C 9594 Wayne Behrle Vol#: 476

C 9595 Nellie Ingram Vol#: 476

C 9596 Scott B. Gilhert Vol#: 476

C 9597 Lawrence Lejfer Vol#: 476

C 9598 Philip Blanchfield Vol#: 476

C 9599 Kathryn Parry Vol#: 476

C 9600 Wesley Strong Vol#: 476

C 9601 Kevin M. Beahan Vol#: 476

C 9602 Joshua Park Vol#: 476

C 9603 Tim Kelesar Vol#: 476

C 9604 Donna Minster Vol#: 476

C 9605 Grace Jeon Vol#: 476

C 9606 Dawn Hoffman Vol#: 476

C 9607 Ian R. Arthur Vol#: 476

C 9608 Michael S. Smith Vol#: 476

C 9609 Mitch Harris Vol#: 476

C 9610 Jody Wolfe Vol#: 476

C 9611 Valerie Graber Vol#: 476

C 9612 Judy Ambrose Vol#: 476

C 9613 Morgan Broderick Vol#: 476

C 9614 Jennifer L. Dorward Vol#: 476

C 9615 Nathaniel Whitmore Vol#: 476

C 9616 Kevin Uehlinger Vol#: 476

00E-1235 Patent Extension, Aciphex (rabeprazole)

LET 2 HFD-005 to U.S. Patent and Trademark Off Vol#: 1

00N-1525 Debarment of Richard Elliott Humphreys;Notice of Opportunity

SUP 1 Richard E. Humphreys Vol#: 1

00P-1077 Amend Current Reg Banning Sale of Small Turtles

LET 2 HF-40 to Mr. Devin Edmonds Vol#: 2

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

SUP 1 Unilever Bestfoods North America Vol#: 18

00P-1276 Health Claim: Plant stanol esters and heart disease

SUP 1 Unilever Bestfoods North America Vol#: 18

00P-1322 Food Labeling and Allergen Contamination Control

C 486 Deborah Berger Vol#: 29

C 487 Deborah Berger Vol#: 29

C 488 Geraldine C. Rarig Vol#: 29

C 489 Louise Rogers Vol#: 29

C 490 Robert Stapp Vol#: 29

C 491 Ronny Carny Vol#: 29

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

C 4 3M Pharmaceuticals Vol#: 1

01H-0065 Civil Money Penalty for First Check Home Drug Test Devices

RMO 1 GCF-1 Vol#: 1

01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA

RC 1 Public Citizen Vol#: 1

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

C 3 Doreen M. Wiersch Vol#: 1

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

ACK 1 HFA-305 Vol#: 1

CP 1 Meridian Medical Technologies Vol#: 1

01V-0538 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Beaming man Vol#: 1

01V-0543

ACK 1 HFA-205 Vol#: 1

VAR 1 Laserdome Vol#: 1