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

Hyper links are part of the Docket  title - not all dockets/documents are linked

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

PLEASE DO NOT  include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence.

[FDA DOCKETS PAGE] [FDA HOME PAGE]  [ ITEM CODES ]

 
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