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 20, 2001

TABLE OF CONTENTS

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99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu *
99P-1654 Stay Effect Date for Approval of ANDA for generic DIPRIVAN *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
00P-1322 Food Labeling and Allergen Contamination Control *
01D-0278 Submitting Type V Drug Master Files to Center for Biologics *
01D-0361 Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0524 Hydrocodone Bitartrate & Acetaminophen Oral Solution 10 mg *
77N-0085 Saccharin and Its Salts

CA 16768 Norma J. Parker Vol#: 389

CA 16842 OPINION BALLET Vol#: 390

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

C 3 Center for Food Safety & Public Citizen Vol#: 2

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

C 3 Center for Food Safety & Public Citizen Vol#: 2

99F-5322 Ionizing Radiation for the Treatment of Food

C 3 Center for Food Safety & Public Citizen Vol#: 1

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

C 4 Center for Food Safety & Public Citizen Vol#: 1

99P-1654 Stay Effect Date for Approval of ANDA for generic DIPRIVAN

SUP 1 AstraZeneca Pharmaceuticals Vol#: 2

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9145 Nathaniel Whitmore Vol#: 401

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

C 18 McNeil Nutritionals Vol#: 19

C 19 Raisio Benecol Ltd Vol#: 20

C 20 Cargill, Inc. Vol#: 22

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

C 21 McNeil Nutritionals Vol#: 19

C 22 Raisio Benecol, Ltd. Vol#: 20

C 23 Cargill, Inc. Vol#: 22

00P-1322 Food Labeling and Allergen Contamination Control

C 483 Gladys Johnson Vol#: 29

01D-0269 Clinical Studies Section for Prescription Drugs & Biologics

NAD 2 Vol#: 1

01D-0278 Submitting Type V Drug Master Files to Center for Biologics

C 2 Abbott Laboratories Vol#: 1

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

C 1 Aventis Pharmaceuticals Vol#: 1

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

GDL 1 Guidance Vol#: 1

NAD 2 Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

C 3 Center for Food Safety & Public Citizen Vol#: 2

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

CH 11 State of California Vol#: 5

CH 12 World Renderers Organization Vol#: 5

CH 13 North American Rendering Industry Vol#: 5

CH 14 AAFCO Vol#: 5

CH 15 State of North Carolina's Vol#: 5

CH 16 Association of American Railroads Vol#: 5

01N-0464 Vaccine Adverse Event Reporting System

N 1 Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 395 Jesse Sia Vol#: 80

C 396 E. Lutz Vol#: 80

C 397 William & Elizabeth Wittkoff Vol#: 80

C 398 Barbara Vaile Vol#: 80

C 399 Tamara Li Vol#: 80

C 400 Marion Goodale Vol#: 80

C 401 Tonja Jones Vol#: 80

C 402 Jo Carson Vol#: 80

C 403 Dorothy L. Frantz Vol#: 80

C 404 Jean Maier Vol#: 80

C 405 Gary McDonald Vol#: 80

C 406 Charles Marino Vol#: 80

C 407 Dr. Mark Schecter Vol#: 80

C 408 Jennifer Lebell Vol#: 80

C 409 Danielle Creeksong Vol#: 80

C 410 D. E. Munyon Vol#: 80

C 411 Rudolf W. Becking Vol#: 80

C 412 Elizabeth Levy Merrick Vol#: 80

C 413 Ms. Billie Bowman Vol#: 80

C 414 Evelyn Walden Vol#: 80

C 415 Tom Hesseldenz Vol#: 80

C 416 D. Miller Vol#: 80

C 417 Donna Kievit Vol#: 80

C 418 Gabrielle Wellman Vol#: 80

C 419 Ralph Lutz Vol#: 80

C 420 Don D. Maronde Vol#: 80

C 421 Mary Burney Vol#: 80

C 422 Ruth I. Morton Vol#: 80

C 423 Kerry Kaluza Vol#: 80

C 424 Kasia Welin Grossman Vol#: 80

C 425 Mikhaela Maricich Vol#: 80

C 426 Diane dos Santos Vol#: 80

C 427 Josephine Rapatz Vol#: 80

C 428 Matthew P. Erickson Vol#: 80

C 429 Lorrie Leigh Vol#: 80

C 430 Larry D. Corridon Vol#: 80

C 431 Connie Rogers Vol#: 80

C 432 Wendell Funk Vol#: 80

C 433 Laura Beck Vol#: 80

C 434 Stacey Ludlow Vol#: 80

C 435 Ailene Glatter Vol#: 80

C 436 Shawna Grant Vol#: 80

C 437 Shelley Anne Grant Vol#: 80

C 438 Ken Grant Vol#: 80

C 439 Timothy Erentta Vol#: 80

C 440 Randy Borchardt Vol#: 80

01P-0524 Hydrocodone Bitartrate & Acetaminophen Oral Solution 10 mg

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1