Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870; TTY/TDD Users 1-800-735-2258 - [E-mail Us]

DOCKETS ENTERED on November 13, 2002

TABLE OF CONTENTS

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75N-183H Health-Care Antiseptic Drug Products for OTC Human Use *
83A-0339 ADVISORY OPINION - OTC DRUG PROD LABLED AS STIMULANT *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0377 Methadone Hydrochloride Tablets, USP 15mg, 20 mg, 30 mg & 40 *
02D-0320 Hold following clinical investigator misconduct *
02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate *
02D-0333 Juice HACCP Hazards and Controls *
02D-0385 Approval of Labeling for Foods Treated by Irradiation *
02N-0209 Governing First Amendment Case Law *
02N-0275 Bioterrorism Preparedness; Administrative Detention *
02N-0393 Draft Action Plan on Acrylamide *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02N-0456 Determine Hosp. Proc. for Opened-But-Unused, Single Use Devi *
02N-0466 Safety, Clinical and Immune Response of Dryvax *
02P-0084 ANADA for a generic version of trimethoprim & sulfadiazine c *
02P-0189 Physical form of drug product in to a oral liquid generic *
02P-0198 ANADA for ivermectin having a different dosage form (oral ge *
02P-0469 ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2% *
02P-0483 Actions re: exceptive drug products, ex release guaifenesin *

75N-183H Health-Care Antiseptic Drug Products for OTC Human Use

LET 32 HFD-1 to Lonza, Inc. Vol#: 60

83A-0339 ADVISORY OPINION ON OTC DRUG PROD LABLED AS STIMULANT

M 1 GCF-1 Vol#: 1

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 61 Arthur & Margaret Walsh Vol#: 2

C 62 Alexandra Waring Vol#: 2

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 6076 Olive McKinney Vol#: 264

C 6077 Dorothy Hayes Vol#: 264

C 6078 Deronda Cotrofeld Vol#: 264

C 6079 Alice M. McTague, R.N. Vol#: 264

C 6080 Beverly MacKeyin Vol#: 264

C 6081 Cindy Overly-Diamond Vol#: 264

C 6082 Michele L. Pava Vol#: 264

C 6083 Mrs. Edith Lawton Vol#: 264

C 6084 Donna Lanciotti Vol#: 264

C 6085 Ronald J. Kopski Vol#: 264

C 6086 Mary F. DeKlyn Vol#: 264

C 6087 Peter Mathews Vol#: 264

C 6088 Ms. Jami Tolpin Vol#: 264

C 6089 B. Starr Solomon Vol#: 264

C 6090 Charles F. Colao, M.D., P.A. Vol#: 264

C 6091 Pierce E. Tuttle Vol#: 264

C 6092 Chris Mathews Vol#: 264

C 6093 Sherry Golden Vol#: 264

C 6094 John Riddell Vol#: 264

C 6095 Shannon Reed Vol#: 264

C 6096 Toni Siegrist Vol#: 264

C 6097 Elvina & Richard Kinch Vol#: 264

C 6098 Denise M. De Sarlo Vol#: 264

C 6099 Janice Emich Vol#: 264

C 6100 Sharon Axtell-Troutt Vol#: 264

C 6101 Kelly Ann Duddy et al Vol#: 264

C 6102 Linda A. LaCross Vol#: 265

C 6103 Marcia Balbus Vol#: 265

C 6104 Miss Jocelyn Farrell Vol#: 265

C 6105 Vaughan Dewar Vol#: 265

00D-1539 Electronic Records & Signatures, Retention of Electronic Rec

EC 4 Number Not Used Vol#: 6

00N-1526 Proposal to Debar Robert A. Fiddes,M.D.;Notice of Oppportuni

N 1 Vol#: 1

00N-1528 Proposal to Debar Delfina Hernandez;Notice of Opportunity

N 1 Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

CS 14 HFA-305 Vol#: 270

OR 15 HF-3 Vol#: 270

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 1244 Tanya Bell Vol#: 226

C 1245 Elizabeth Chlyster Vol#: 226

C 1246 Thom Prentice, Ph.D. Vol#: 226

C 1247 University of California Vol#: 226

C 1248 C. J. Puotinen Vol#: 226

C 1249 Colene Lee Vol#: 226

EMC 2525 Lizabeth O. Southworth Vol#: 220

EMC 2526 Ruth Fink-Winter Vol#: 220

EMC 2527 Kathleen Farley Vol#: 220

EMC 2528 Gail Fricke Vol#: 220

01P-0350 Determine whether Sotradecol has been withdrawn from sale in

N 1 Vol#: 1

01P-0377 Methadone Hydrochloride Tablets, USP 15mg, 20 mg, 30 mg & 40

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

02D-0320 Hold following clinical investigator misconduct

C 2 Abbott Laboratories Vol#: 1

02D-0324 Bioengineered Plants for Use in Humans and Animals

C 18 Katherine Kaenum Vol#: 1

C 19 Gail R. Gilbert Vol#: 1

C 20 Janet Kimball Vol#: 1

C 21 Donald J. Gier Vol#: 1

C 22 Betty E. Schilling Vol#: 1

C 23 Penelope Bullis Vol#: 1

C 24 Joyce Frohn Vol#: 1

C 25 Claire A. Nirola Vol#: 1

C 26 Manfred McArthur Vol#: 1

C 27 Manfred McArthur Vol#: 1

02D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

C 4 Kim Zanti Vol#: 1

C 5 Kathy Lane Vol#: 1

C 6 Miller Children's Hospital Vol#: 1

EC 1 Mr. Gerardo Vargas Vol#: 1

02D-0333 Juice HACCP Hazards and Controls

C 3 International Diary Foods Assn Vol#: 1

C 4 Brown International Corporation Vol#: 1

C 5 National Juice Products Assn Vol#: 1

C 6 Florida Citrus Processors Assn Vol#: 1

C 7 FMC Tecnologics, Inc. Vol#: 1

02D-0349 Transcutaneous Air Conduction Hearing Aid System

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

02D-0385 Approval of Labeling for Foods Treated by Irradiation

EC 4 Global Marketing Assoc. inc Vol#: 1

02D-0449 Administrative New Animal Drug Appilication Process

GDL 1 Guideline Vol#: 1

NAD 1 Vol#: 1

02F-0327 ADM Alliance Nutrition, Inc.;Animal Use Feed-Grade Biuret

EC 3 none Vol#: 1

EC 4 Number Not Used Vol#: 1

02H-0443 Civil Money Penalty Re: LaHaye Ctr.for Advanced Eye Care

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

02M-0145 P010030; WCD 2000 System

N 1 Vol#: 1

02M-0167 Amplatzer PFO Occuluder, H000007

N 1 Vol#: 1

02M-0172 P980024/S001; PathVysion HER-2 DNA Probe Kit

N 1 Vol#: 1

02M-0173 P010025; Lorad Digital Breast Imager (LDBI)

N 1 Vol#: 1

02M-0174 P010018; ViewPoint CK System

N 1 Vol#: 1

02M-0179 P010054; Elecsys Anti-HBs Immunoassay & Elecsys PreciControl

N 1 Vol#: 1

02M-0180 Model AC21B UV-Absorb'g PMMA Anterior Chamber Intraocular Le

N 1 Vol#: 1

02M-0203 WALLSTENT Venous Endoprosthesis w/Unistep Plus RP Delivery

N 1 Vol#: 1

02M-0216 P900033/S008; Dermal Regeneration Template

N 1 Vol#: 1

02M-0217 Medtronic Activa Parkinson's Control Therapy, P960009/s0007

N 1 Vol#: 1

02M-0218 PMA QuantiFERON-tb, P010033

N 1 Vol#: 1

02M-0235 PMA IntraCoil Self-expanding Peripheral Stent, P000033

N 1 Vol#: 1

02M-0236 PMA Contak CD CRT-D System & EASYTRAK Coronary Venous Steroi

N 1 Vol#: 1

02M-0250 PMA LAP-Band Adjustable Gastric Banding (LAGB) System

N 1 Vol#: 1

02M-0255 PMA On-X Prosthetic Heart Valve, Models ONXM & ONXMC

N 1 Vol#: 1

02M-0271 P000039; AMPLATZER Septal Occluder (ASO) & Exchange System

N 1 Vol#: 1

02M-0272 P000049; CardioSEAL Septal Occlusion System with QwikLoad

N 1 Vol#: 1

02M-0311 PMA VISX Excimer Laser System & Custome Contoured Ablation

N 1 Vol#: 1

02N-0209 Governing First Amendment Case Law

C 102 IMDMC, Indiana Medical Device Mfrs Counc Vol#: 19

02N-0273 Animal Proteins Prohibited in Ruminant Feed

NPR 1 Vol#: 1

02N-0275 Bioterrorism Preparedness; Administrative Detention

EC 15 Fleet Medical Resources Vol#: 3

02N-0393 Draft Action Plan on Acrylamide

TR 1 Transcript for 09/30/02 public meeting Vol#: 2

02N-0445 FDA Regulation of Combination Products; Public Hearing

APE 27 SFC/Solvent Free Corporation Vol#: 3

EAPE71 Berlex Laboratories, Inc. Vol#: 3

EAPE72 AAOS Vol#: 3

EAPE73 Georgia Tech/Emory Center Vol#: 3

EAPE74 Ethicon Endo-Surgery Vol#: 3

EAPE75 Ethicon Endo-Surgery Vol#: 3

EC 7 Number Not Used Vol#: 1

EC 8 Tunstall and Associates, LLC Vol#: 3

02N-0456 Determine Hosp. Proc. for Opened-But-Unused, Single Use Devi

EC 24 P Vol#: 1

EC 25 Departement of Veterans Affairs Vol#: 1

02N-0466 Safety, Clinical and Immune Response of Dryvax

EC 211 Mrs. Jessica Smith Vol#: 3

EC 212 Mrs. Lindsay Wolsey Vol#: 3

EC 213 Number Not Used Vol#: 3

EC 214 VA Vol#: 3

EC 215 Ms. Irene Wilson Vol#: 3

EC 216 Mrs. Brandi Blaesing Vol#: 3

EC 217 Ms. Katherine Owens Vol#: 3

EC 218 Mrs. Kelly Ford Vol#: 3

EC 219 Ms. Karen Podesta Vol#: 3

EC 220 Mrs. J. Jones Vol#: 3

EC 221 Dr. Demelza Costa Vol#: 3

EC 222 Concerned US Citizen Vol#: 3

EC 223 Mrs. Kelly Hoffman Vol#: 3

EC 224 Mrs. Sheila Ealey Vol#: 3

EC 225 Mr. Christopher Masterjohn Vol#: 3

EC 226 Dr. Margaret Kluthe Vol#: 3

EC 227 Mrs. Debra Lamb Vol#: 3

EC 228 Mrs. Debra Lamb Vol#: 3

EC 229 Ms. Kim Liberty Vol#: 3

EC 230 n/a Vol#: 3

EC 231 Miss Naomi Pestana Vol#: 3

EC 232 Mrs. Michelle Pinkowski Vol#: 3

EC 233 Ms. Laila Barker Vol#: 3

EC 234 Mr. Jeremy Beireis Vol#: 3

EC 235 Citizen of the United States Vol#: 3

EC 236 Concerned Citizen of the U.S. Vol#: 3

02P-0084 ANADA for a generic version of trimethoprim & sulfadiazine c

PAV 1 HFV-130 to Pharmaceutical Solutions, Inc Vol#: 1

02P-0189 Physical form of drug product in to a oral liquid generic

PAV 1 HFV-130 to Phoenix Scientific, Inc. Vol#: 1

02P-0198 ANADA for ivermectin having a different dosage form (oral ge

PAV 1 HFZ-130 to Richdel, Inc. Vol#: 1

02P-0241 Classification of Transscutaneous Air Conduction Hearing Aid

NFR 1 Vol#: 1

02P-0469 ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2%

LET 1 Hyman, Phelps & McNamara, PC Vol#: 1

02P-0483 Actions re: exceptive drug products, ex release guaifenesin

ACK 1 HFA-305 Vol#: 1

CP 1 Kirkpatrick & Lockhart, LLP et al Vol#: 1