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 December 27, 2000

TABLE OF CONTENTS

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78N-0301 OTC External Analgesic Drug Products *
93N-0200 Quality Stds For Foods w/o Identity Standards; Bottled Water *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1497 Mammography Quality Standards Act; Final Regs Document #4 *
00D-1601 Guidance for Industry and for FDA Employees on Import Alert *
00N-1567 Registration of Producers of Drugs & Listing of Drugs *
00N-1610 Digoxin Products Oral Use;Revocation conditions marketing *
00P-1370 ANDA for generic verions of Zaroxolyn Tablets(metolazone *
00P-1499 Remove alosetron (Lotronex) from the market *
00P-1500 Allow Dietary Supple Mfg to list ingredients aphabetically *
00P-1550 Approve ANDA for Cefuroxime Axetil Products *
78N-0301 OTC External Analgesic Drug Products

PDN 3 HFC-1 to Chattem Inc Vol#: 99

93N-0200 Quality Stds For Foods w/o Identity Standards; Bottled Water

C 90 Olympia J. Snowe (CI) Vol#: 3

C 91 Rick A. Lazio (CI) Vol#: 3

C 92 Brian Bilbray (CI) Vol#: 3

C 93 Susan M. Collins (CI) Vol#: 3

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

C 3219 Candace Allaman Vol#: 99

C 3220 Mrs. Rita Flygar Vol#: 99

C 3221 A. Monro Masonis Vol#: 99

C 3222 April Lang Vol#: 99

C 3223 Nina Taylor Vol#: 99

C 3224 Mrs. Francine Tisch Vol#: 99

C 3225 Bobbie Medley Vol#: 99

C 3226 Mr. Carroll E. Lysinger Vol#: 99

C 3227 Selma Effron Vol#: 99

C 3228 Barbara Stasz Vol#: 100

EMC 476 Shendl Diamond Vol#: 99

EMC 477 John & Nancy Arnold Vol#: 99

EMC 478 Shauna Amistoso Vol#: 99

EMC 479 Thomas P, Metcal Vol#: 99

EMC 480 Kim Grunden Vol#: 99

EMC 481 Kelly Wright Vol#: 99

EMC 482 Allison Sumrow Vol#: 99

EMC 483 Mrs. Barie Thomas-Bass Vol#: 99

EMC 484 Jeffrey Klein Vol#: 99

EMC 485 Joan Weber Vol#: 99

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

EMC 67 Dr. Kevin Kuehlwein Vol#: 190

EMC 68 Tera Stockdale Vol#: 190

EMC 69 David Michaelson Vol#: 190

EMC 70 Allison Vetter Vol#: 190

EMC 71 Philip H. Coe Vol#: 190

EMC 72 Sharon Marie Plain Vol#: 190

EMC 73 Samuel Paden Vol#: 190

00D-1223 Clinical Investigation of Medicinal Products in Pediatrics

GDL 1 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

00D-1309 Channels trade policy commodities with methyl parathion

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00D-1497 Mammography Quality Standards Act; Final Regs Document #4

C 7 IMS, Intl Medico Scientifica (Italy) Vol#: 1

C 8 Medical Physics Consultants, Inc. Vol#: 1

C 9 GE Medical Systems Vol#: 1

C 10 ACR, American College of Radiology Vol#: 1

C 11 William Beaumont Hospital Vol#: 1

C 12 Oregon Health Sciences University Vol#: 1

00D-1601 Guidance for Industry and for FDA Employees on Import Alert

C 1 AAC Consulting Group, Inc. Vol#: 1

00M-0809 P990023;Cellugel Ophthalmic Viscosurgical Device

NAD 2 Vol#: 1

00M-1386 Hyperion LTK System, P990078

NAD 1 Vol#: 1

00M-1387 P990021; Diomed 630 PDT Laser, Model T2USA

NAD 1 Vol#: 1

00M-1388 NAVI-STAR Diagnostic/Ablation Deflectable Tip Cathether

NAD 1 Vol#: 1

00M-1389 Jewel AF 7250 Dual Chamber implantable Cardioverter Difibril

NAD 1 Vol#: 1

00M-1390 Vascular Solutions Duett Sealing Device, P990037

NAD 1 Vol#: 1

00M-1391 P930016/S7; VISX STAR S2 Excimer Laser System

NAD 1 Vol#: 1

00M-1414 P990018 Menicon Ztm(tisilfocon A)Rigid Gas Permeable Lens

NAD 1 Vol#: 1

00M-1415 P000006 Mentor Alpha 1 Inflatable Penile Prosthesis

NAD 1 Vol#: 1

00M-1416 P990064 Mosaic Porcine Bioprosthesis, Models 305 and 310

NAD 1 Vol#: 1

00M-1437 P990039;QUS-2 Calcaneal Ultrasonometer

NAD 1 Vol#: 1

00M-1447 PMA Visx Inc Excimer Laser System Model C (STAR S2)

NAD 1 Vol#: 1

00M-1448 PMA OxiFirst Fetal Oxygen Saturation Monitoring System

NAD 1 Vol#: 1

00M-1451 H990014; Enterra Therapy System

NAD 1 Vol#: 1

00M-1475 P990072; Horizon 55 EW & Horizon 55 EW Westint

NAD 1 Vol#: 1

00M-1483 PMA Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis

NAD 1 Vol#: 1

00M-1495 PMA Medtronic IsoMed Constant Flow Infusion System P990034

NAD 1 Vol#: 1

00M-1507 PMA FocalSeal-L Synthetic Absorbable Sealant P990028

NAD 1 Vol#: 1

00M-1508 PMA Apligraf (Graftskin) P950032/S016

NAD 1 Vol#: 1

00M-1515 Medstone STS Lithotripter for treatment of gallstones

NAD 1 Vol#: 1

00M-1517 PMA Chilli Cooled Ablation System P990054

NAD 1 Vol#: 1

00M-1522 PMA Matritech NMP22 Test Kit, P940035/S002

NAD 1 Vol#: 1

00M-1523 PMA AIA-Pack PA, P910065/S001

NAD 1 Vol#: 1

00M-1524 PMA Bayer Immuno 1 Complexed PSA Assay, P990055

NAD 1 Vol#: 1

00M-1536 PMA PSA2 Immunoassay on Chiron Diagnostics ACS:180 & ACS Cen

NAD 1 Vol#: 1

00N-1269 Labeling for human prescription drug/Biologic Products

BKG 1 BACKGROUND Vol#: 2

NPR 1 Vol#: 1

00N-1353 CGMP & Related Regs for Blood & Blood Components;Information

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

00N-1501 Treshold of Regulation for Subances Used in Food-Contact

N 2 Vol#: 1

00N-1502 Adverse Experience Reporting for Licensed Biological Product

N 2 Vol#: 1

00N-1504 Using E-mail to Submit Info to Center for Veterinary Med

SS 1 Supporting Statement Vol#: 1

00N-1567 Registration of Producers of Drugs & Listing of Drugs

C 1 Hoffmann-La Roche, Inc. Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 4 Allen's Hatchery, Inc. Vol#: 16

C 5 Allen's Hatchery, Inc. Vol#: 16

EXT 1 Bayer Corp. Vol#: 16

00N-1610 Digoxin Products Oral Use;Revocation conditions marketing

C 1 Jerome Stevens Pharms Vol#: 1

00P-1370 ANDA for generic verions of Zaroxolyn Tablets(metolazone

LET 1 HFD-1 to Medeva Pharmaceuticals, Inc Vol#: 1

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

C 62 University Hospitals Health System Vol#: 3

00P-1500 Allow Dietary Supple Mfg to list ingredients aphabetically

C 1 Intelisoft Multimedia, Inc. Vol#: 1

00P-1550 Approve ANDA for Cefuroxime Axetil Products

LET 1 Glaxo Wellcome Vol#: 2

00P-1554 Exempt pharmacy compounding systems/Class II devices from PM

N 1 Vol#: 1