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 12, 2002

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88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
02N-0445 FDA Regulation of Combination Products; Public Hearing *
02N-0466 Safety, Clinical and Immune Response of Dryvax *
02P-0481 Methadone Hydrochloride Tablets, USP, 15mg, 20mg and 30(ANDA *

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

ACK 4 HFA-305 Vol#: 6

PSA 3 Pharmaceutical Distributors Association Vol#: 6

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

ACK 4 HFA-305 Vol#: 8

PSA 3 Pharmaceutical Distributors Association Vol#: 8

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

EMC 2 Form Letter count Vol#: 5

EMC 3 Form Letter count Vol#: 6

00D-1540 Electronic Signatures, Electronic Copies of Electronic Recor

GDL 1 GUIDANCE Vol#: 6

NAD 1 Vol#: 6

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

MO 16 Center for Veterinary Medicine Vol#: 320

MO 17 Center for Veterinary Medicine Vol#: 321

RMO 11 Bayer Corporation Vol#: 270

02D-0011 Intraoral Devices for Snoring/Obstructive Sleep Apnea

GDL 2 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

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

EXT 1 LaHaye Center dba LaHaye Total Eye Care Vol#: 1

02N-0010 Intraoral Devices for Snoring/Obstructive Sleep Apnea

NFR 1 Vol#: 1

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

APE 17 Genetronics, Inc. Vol#: 2

APE 18 Holland & Knight LLP Vol#: 2

APE 19 Eli Lilly & Company Vol#: 2

APE 20 Medical Devices Manufacturers Associatio Vol#: 2

APE 21 Nephros Therapeutics, Inc. Vol#: 2

APE 22 Medical Devices Group, Div of Ethicon In Vol#: 2

APE 23 Aerogen, Inc. Vol#: 2

APE 24 Altana Pharma Vol#: 2

APE 25 Novo Nordisk Pharmaceuticals, Inc. Vol#: 3

APE 26 GlaxoSmithKline Vol#: 3

CH 1 AdvaMed Vol#: 1

EAPE36 American Red Cross Vol#: 3

EAPE37 Smith & Nephew, Inc. Vol#: 3

EAPE38 Inhale Therapeutic Systems Vol#: 2

EAPE39 Hoffmann-La Roche Inc. Vol#: 3

EAPE40 NEMA/Philips Medical Systems Vol#: 3

EAPE41 Wyeth Pharmaceuticals, Inc. Vol#: 3

EAPE42 Eli Lilly and Company Vol#: 3

EAPE43 Smith & Nephew, Inc. Vol#: 3

EAPE44 Synecor, LLC Vol#: 3

EAPE45 Johnson & Johnson Pharmaceutical R&D Vol#: 3

EAPE46 Navigators-Charles River Laboratories Vol#: 3

EAPE47 Angiogene Inc Vol#: 3

EAPE48 American College of Cardiology Vol#: 3

EAPE49 Alquest, Inc. Vol#: 3

EAPE50 Wyeth Pharmaceuticals Vol#: 3

EAPE51 Eminent Research Systems, Inc. Vol#: 3

EAPE52 Biomerix Vol#: 3

EAPE53 Hogan & Hartson LLP Vol#: 3

EAPE54 FDA/CDER Vol#: 3

EAPE55 FDC Reports Vol#: 3

EAPE56 FDC Reports Vol#: 3

EAPE57 Carnegie Mellon University Vol#: 3

EAPE58 Coley Pharmaceutical Group, Inc. Vol#: 3

EAPE59 Kruger Consulting, Inc. Vol#: 3

EAPE60 American Medical Systems Vol#: 3

EAPE61 Carnegie Mellon University Vol#: 3

EAPE62 Hyman, Phelps & McNamara, P.C. Vol#: 3

EAPE63 Stryker Biotech Vol#: 3

EAPE64 Alpine Group Vol#: 3

EAPE65 Abbott Laboratories Vol#: 3

EAPE66 AdvaMed Vol#: 3

EAPE67 BonScience Vol#: 3

EAPE68 Iomai Corporation Vol#: 3

EAPE69 Iomai Corporation Vol#: 3

EAPE70 AdvaMed Vol#: 3

EC 4 Genetronics, Inc Vol#: 1

EC 5 Number Not Used Vol#: 1

EC 6 Number Not Used Vol#: 1

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

EC 183 Mr. Daryl Suzukawa Vol#: 3

EC 184 Mr. Ronald Myers Vol#: 3

EC 185 Ms. stephanie jones Vol#: 3

EC 186 Mrs. Martha Begly Vol#: 3

EC 187 Mr. Marcus Kerske Vol#: 3

EC 188 Ms. cyndi ringoen Vol#: 3

EC 189 Dewey Ross Duffel Vol#: 3

EC 190 Mr. John Buder Vol#: 3

EC 191 Mr. Charles Drummond Vol#: 3

EC 192 Mrs. Deborah Drummond Vol#: 3

EC 193 Mrs. Karen Riegelman Vol#: 3

EC 194 Mr. Tel Tofflemire Vol#: 3

EC 195 Mrs. Nancy Lou De Lise Vol#: 3

EC 196 Mr. Phil Stravers Vol#: 3

EC 197 Ms. N.B. Downes Vol#: 3

EC 198 Mrs. Holly Kastl Vol#: 3

EC 199 WL Corporon MD, Inc Vol#: 3

EC 200 Mr. Jerod Stutsman Vol#: 3

EC 201 Ms. Lois Furry Vol#: 3

EC 202 Dr. Marie Trenga Vol#: 3

EC 203 Dr. Mischa Doman Vol#: 3

EC 204 Children's Mercy Hospital Vol#: 3

EC 205 Mrs. Cassidy Hummel Vol#: 3

EC 206 Dr. Anna Madland Vol#: 3

EC 207 Mrs. Melanie Coopeer Vol#: 3

EC 208 Ms. Christine Palermo Vol#: 3

EC 209 Mrs. Kathryn Bush Vol#: 3

EC 210 Dr. jennifer anacker Vol#: 3

02P-0481 Methadone Hydrochloride Tablets, USP, 15mg, 20mg and 30(ANDA

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc Vol#: 1

02V-0482 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Sonic Wave Vol#: 1