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 19, 2001

TABLE OF CONTENTS

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NOTE:  Documents received by the Dockets Management Branch "MAY" be posted on the Internet.

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78N-0038 Sunscreen Drug Products *
94P-0354 Certify Mercury/Silver (amalgam)-Classify & Issue Warning *
97N-484P Current Good Tissue Practice for Mfrs. of Human Cellular *
99D-5046 Human Blood & Blood Components Intended for Transfusion *
99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-5106 Identify Sources of Natural Flavorings *
99P-5198 Request amendment of the definition of milk *
00N-1665 Consumer Roundtable; Notice of Meeting *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1603 Rescind Any Contraindications For Use of Misoprostol In Preg *
01D-0221 Biological Product Deviation Reporting for Licensed Manufact *
01D-0269 Clinical Studies Section for Prescription Drugs & Biologics *
01D-0368 Submitting Marketing Applications according to ICH/CTD Forma *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01N-0398 Format and Content Requirements for OTC Drug Product Labelin *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01N-0459 Food Labeling; Notification Procedures on Dietary Supplement *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0345 Listing the color additive yellow #5 for use in food/Drug *
01P-0396 Request that FDA ban the production and sale of all ephedra *
01P-0425 ANADA Suitability for Heartgard 30 Chewables *
01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II *
77N-0085 Saccharin and Its Salts

CA 15910 NUMBER NOT USED Vol#: 380

CA 15933 Number not used Vol#: 380

CA 16059 Frances Bevis Vol#: 382

CA 16396 Donna Jeanne Morean Vol#: 385

78N-0038 Sunscreen Drug Products

mm0023.pdf

93N-0195 Safe Processing & Importing of Fish & Fishery Products

EC 1 Number Not Used Vol#: 25

94P-0354 Certify Mercury/Silver (amalgam)-Classify & Issue Warning

EMC 1 Owen Ward Vol#: 1

97N-484P Current Good Tissue Practice for Mfrs. of Human Cellular

C 47 U.S. Small Business Administration Vol#: 5

99D-5046 Human Blood & Blood Components Intended for Transfusion

EC 2 Mrs. Yvonne Forteza Vol#: 1

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

EMC 99 Center for Food Safety Vol#: 2

EMC 100 Herb Jacobs Vol#: 2

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

EMC 2 Center for Food Safety Vol#: 2

EMC 3 Herb Jacobs Vol#: 2

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 872 Barbara Holtz Vol#: 209

EMC 873 Charles Rinehart Vol#: 209

EMC 874 Bob Marconi Vol#: 209

99P-1340 Declared Eternity eau de Parfum Misbranded

C 734 Michelle Deckys Vol#: 18

EMC 346 Liz Reichenbach Vol#: 18

EMC 347 Janet Collins Vol#: 18

EMC 348 William Barstad Vol#: 18

99P-5106 Identify Sources of Natural Flavorings

EMC 129 Jeremy Franklin Vol#: 2

EMC 130 Ashok & Lisa Iyer Vol#: 2

99P-5198 Request amendment of the definition of milk

C 3 George J. Wilberg Vol#: 1

99V-4323 Laser Light Show in Space Theater

EXP 1 AVI Vol#: 1

00N-1665 Consumer Roundtable; Notice of Meeting

EC 26 Federal Employee Vol#: 1

EC 27 Federal Employee Vol#: 1

00P-1210 Restrict Sale of Coal Tar-Containing Products

EMC 1 State of California Office of the Attorn Vol#: 10

00P-1322 Food Labeling and Allergen Contamination Control

C 481 36 Signatures Vol#: 29

C 482 Gluten-Free Living Vol#: 29

EMC 451 Catalina Ferre Hockensmith Vol#: 20

EMC 452 Catalina Ferre Hockensmith Vol#: 20

00P-1499 Remove alosetron (Lotronex) from the market

EMC 270 Debra C. Young Vol#: 6

00P-1603 Rescind Any Contraindications For Use of Misoprostol In Preg

EMC 6 Sarah Elizabeth Aadland Vol#: 1

01D-0221 Biological Product Deviation Reporting for Licensed Manufact

C 7 Abbott Laboratories Vol#: 1

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

C 5 Pharmacia Corporation Vol#: 1

C 6 GlaxoSmithKline Vol#: 1

01D-0368 Submitting Marketing Applications according to ICH/CTD Forma

EC 2 Quintiles, Inc. Vol#: 1

EC 3 Purepac Pharmaceutical Co. Vol#: 1

EC 4 Hoffmann-La Roche Vol#: 1

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

EMC 100 Center for Food Safety Vol#: 2

EMC 101 Herb Jacobs Vol#: 2

01M-0507 P990012; Elecsys HBsAg Immunassay, Elecsys HBsAg Confirmator

AAV 1 Roche Diagnostics Corporation Vol#: 1

01M-0508 P000052; GALILEO Intravascular Radiotherapy System

AAV 1 Guidant Corporation Vol#: 1

01M-0509 P010017; SenoScan Full Field Digital Mammography System

AAV 1 Fisher Imaging, Corporation Vol#: 1

01M-0520 P890057/S014; High Frequency Oscillatory Ventilator

AAV 1 SensorMedics Corporation Vol#: 1

01N-0397 Transportation Safety & Potentially Sedating or Impairing

EMC 1 Shelly Moquin Vol#: 2

01N-0398 Format and Content Requirements for OTC Drug Product Labelin

LET 1 Thursday Plantation Labs, LTD (Australia Vol#: 1

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

CH 10 Nutro Products, Inc. Vol#: 1

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

NM 1 Vol#: 1

01N-0459 Food Labeling; Notification Procedures on Dietary Supplement

EC 2 Mr. Robert Boaz Vol#: 1

01P-0169 Access & Safe Distribution of Alosetron

C 109 Lori Syphrit Vol#: 3

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 350 Form Letter count 9 Vol#: 79

C 351 Eleanor A. Hayes Vol#: 51

C 352 Mrs. F. Saudok Vol#: 51

C 353 Anne Legene Vol#: 51

C 354 Lois Grossman Vol#: 51

C 355 Marilyn Gorski Vol#: 51

C 356 Judith Bonnell-Wenzel Vol#: 51

C 357 Ben Katz Vol#: 51

C 358 Jean Moriarty Vol#: 51

C 359 Evelyn L. Walden Vol#: 51

C 360 June Maselbas Vol#: 51

C 361 William D. Green Vol#: 51

C 362 Mary Winne Sherwood Vol#: 51

C 363 Elizabeth Perreault Vol#: 51

C 364 Colleen Duffy Ceile Leidy Vol#: 51

C 365 Therese Forton Vol#: 51

C 366 Maya Brooks Vol#: 51

C 367 Kathy Doyle Vol#: 80

C 368 Deana Voth Vol#: 80

C 369 P. Slader, Jr. Vol#: 80

C 370 K. Liza Loube Vol#: 80

C 371 Carrie Zizza Vol#: 80

C 372 Nancy Hall Vol#: 80

C 373 Tim Bristol Vol#: 80

C 374 Aurah Landau Vol#: 80

C 375 Ted & Donna Kaitchuck Vol#: 80

C 376 Bruce Browning Vol#: 80

C 377 Pamela Gray Vol#: 80

C 378 Lyn Alexander-Larson Vol#: 80

C 379 Kay Robinson Vol#: 80

C 380 Diana Pantle Vol#: 80

C 381 Geraldine Baker Vol#: 80

C 382 Laura Barnard Vol#: 80

C 383 Elisa Gray Vol#: 80

C 384 Jeremiath Gettle Vol#: 80

C 385 Julia Dashe Vol#: 80

C 386 Pamela Hastings OTR Vol#: 80

C 387 Abe Perlstein Vol#: 80

C 388 Marguerite C. Loehre Vol#: 80

C 389 Kerry Bittler Vol#: 80

C 390 Kathy Wilmering Vol#: 80

C 391 Ben Poole Vol#: 80

C 392 Marianne Edain Vol#: 80

C 393 Caroline Gardner Vol#: 80

C 394 Diedre & Gary Jones Vol#: 80

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 779 Deirdre A. Wilson Vol#: 4

EMC 780 Margaret Cox Vol#: 4

EMC 781 No signature Vol#: 4

EMC 782 Kiran Prasad Vol#: 4

EMC 783 Gail Laureen Vol#: 4

EMC 784 No signature Vol#: 4

EMC 785 Pat Dutkiewicz Vol#: 4

01P-0396 Request that FDA ban the production and sale of all ephedra

C 1 Thomas N. Tiedt, PhD Vol#: 1

01P-0425 ANADA Suitability for Heartgard 30 Chewables

PAV 1 HFV-100 to First Priority, Inc. Vol#: 1

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

EMC 13 John F. Sorg Vol#: 1

EMC 14 Gerald Bozarth Vol#: 1

EMC 15 Meryl Nass, MD Vol#: 1

EMC 16 Jeffrey N. Jeffords Vol#: 1

EMC 17 Jim Daniel Vol#: 1

EMC 18 Bruce & Sara-Lee Beller Vol#: 1

EMC 19 Michael McDermott Vol#: 1

EMC 20 Kevin R. Harkness Vol#: 1

EMC 21 Teresa & Ken Jones Vol#: 1

EMC 22 Teresa & Ken Jones Vol#: 1

EMC 23 Christine L. Lincoln Vol#: 1

EMC 24 Ralph Bell Vol#: 1

EMC 25 No signature Vol#: 1

EMC 26 Richard G. Shuster Vol#: 1

EMC 27 Theresa Harmon Vol#: 1