Food and Drug Administration

DOCKETS ENTERED on May 21, 1999

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

92N-0139 Statement Policy: Foods Derived from New Plant Varieties
98N-1038 Irradiation in the production, processing, &handling of food
98N-1265 Distribution of Compounded Drug Products
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0203 Eliminate Forced Molting of Laying Birds
98P-0504 Raw Molluscan Shellfish of Undetectable Levels
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
99P-0033 Combat the spread of transmissible spongiform encephalopathy
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock
99P-1516 To Ban Reprocessed Single Use Devices

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77N-0240 Single-Entity Coronary Vasodilators

LET 29 Time-Cap Labs Vol#: 32

WDL 8 Zeneca Pharmaceuticals Vol#: 32

80N-0228 OTC PROD FOR THE RELIEF OF ORAL DISCOMFORT

WDL 2 Block Drug Company, Inc Vol#: 10

81N-0033 Oral Health Care Drug Products for OTC Human Use

WDL 2 Block Drug Company, Inc. Vol#: 58

92F-0285 Sorbitol as a clarifying agent for polypropylene articles

EA 1 Vol#: 1

FONS2 Vol#: 1

NFR 1 Vol#: 1

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92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5353 Elaine Navias Vol#: 90

C 5354 Nancee Rush Vol#: 90

C 5355 Betsy Wood Vol#: 90

C 5356 Linda Runkle Vol#: 90

C 5357 Heather Wood Vol#: 90

C 5358 Michele Boss Vol#: 90

C 5359 Carol Stevens & 33 signatures Vol#: 90

C 5360 Richard McNamara Vol#: 90

C 5361 Laingdon Schmitt Vol#: 90

C 5362 Jeff Hansel Vol#: 90

C 5363 Imogne DeSmet PhD Vol#: 91

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98E-0789 Patent Extension LOTEMAX and ALREX No. 4,996,335

N 1 Vol#: 1

98F-0342 Acidified Sodium Chlorite Solutions in Poultry Processing

EA 2 Vol#: 1

FONS1 Vol#: 1

NFR 1 Vol#: 1

98F-0824 Amend Food Additive Regs. for Colorants for Polymers

NFR 1 BASF Corp. Vol#: 1

98N-0608 Plasma Protein Fraction (Human)/Immune Globulin (Human)

NFR 1 Vol#: 1

NPR 1 Vol#: 1

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98N-1038 Irradiation in the production, processing, &handling of food

C 1783 Jane Rubey, M.P.H., R.D. Vol#: 39

C 1784 Janet Allen Vol#: 39

C 1785 Irena Franchi & Ilene Arce Vol#: 39

C 1786 Laura Lehner Vol#: 39

C 1787 Carl & Renee Lehner Vol#: 39

C 1788 Intercal LLC Vol#: 39

C 1789 Lesley Young Vol#: 39

C 1790 Irena Franchi & Ilene Arce Vol#: 39

C 1791 Andrew Butz Vol#: 39

C 1792 Laura Sims Vol#: 39

C 1793 Kate K. Davis Vol#: 39

C 1794 Karen Sanchirico Vol#: 39

C 1795 Gary & Nancy Olson Vol#: 39

C 1796 Stewart Skrill Vol#: 39

C 1797 Roswitha & Bernard Lugauer Vol#: 39

C 1798 Tracy Nutbeam Vol#: 39

C 1799 Fred Hodge Vol#: 39

C 1800 Sherry Anderson Vol#: 39

C 1801 Lynne Stephens Vol#: 39

C 1802 Therese Lachecki Vol#: 39

C 1803 Greg Jefford Vol#: 39

C 1804 Mark Seecof Vol#: 39

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98N-1215 Foreign Establishment Registration and Listing

BKG 1 Vol#: 1

NPR 1 Vol#: 1

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98N-1265 Distribution of Compounded Drug Products

C 2415 Cynthia Thomas Vol#: 86

C 2416 Sheree Combs Vol#: 86

C 2417 Marcia Sheilds Vol#: 86

C 2418 Joyce V. Dawson Vol#: 86

C 2419 Bill & Mary Ellen Foster Vol#: 86

C 2420 Kathleen Peterson Vol#: 86

C 2421 Angela Martin Vol#: 86

C 2422 Barbara Glasgow Vol#: 86

C 2423 Janet E. Schrock Vol#: 86

C 2424 Alison & Van Keyes Vol#: 86

C 2425 Nancy N. Ross Vol#: 86

C 2426 Nina McIntosh Vol#: 86

C 2427 Barbara Black Vol#: 86

C 2428 Joan Temkin Vol#: 86

C 2429 Jonnie Hydelotte Vol#: 86

C 2430 Pamela L. Froshaun Vol#: 86

C 2431 H. Yarny Vol#: 86

C 2432 Nancy Peterson Vol#: 86

C 2433 Linda R. Carlson Vol#: 86

C 2434 Evelyn H. Shafer Vol#: 86

C 2435 Darlene Anderson Vol#: 86

C 2436 Janis M. Smith Vol#: 86

C 2437 Deborah A. Taylor Vol#: 86

C 2438 Carolyn Mirane Vol#: 86

C 2439 Carol A. Pesek Vol#: 86

C 2440 Geri Rhodes Vol#: 86

C 2441 C. J. Miller Vol#: 86

C 2442 Sofie & Derry Kirschman Vol#: 86

C 2443 Alma Rugent Vol#: 86

C 2444 Thomas N. Dougherty Vol#: 86

C 2445 Nancy Lagerstedt Vol#: 86

C 2446 Margaret Waggner Vol#: 86

C 2447 Ellen N. Blumin Vol#: 86

C 2448 Shirley Sinko Vol#: 86

C 2449 Elaine Wagner Vol#: 86

C 2450 Margaret Harmon Vol#: 86

C 2451 Sherrie Vavrichek Vol#: 86

C 2452 Diane Margaret Frary Vol#: 86

C 2453 Peggy Teterycz Vol#: 86

C 2454 Cheryl Pawlak Vol#: 86

C 2455 Sandra Pfeffer Vol#: 86

C 2456 Carolyn S. Ray Vol#: 86

C 2457 Marcia A. Henderson Vol#: 86

C 2458 Valerie Soltysiak Vol#: 86

C 2459 Coretta Aparby Vol#: 86

C 2460 Marie Van Loy Vol#: 86

C 2461 Patsy A. Richey Vol#: 86

C 2462 Kathryn Cobb Kramer Vol#: 86

C 2463 Ruth Fioravanti Vol#: 86

C 2464 C. Hernandez Vol#: 86

C 2465 Margaret Steere Vol#: 86

C 2466 Charles Sundry Vol#: 86

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

C 2200 Muriel Beach Vol#: 53

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98P-0203 Eliminate Forced Molting of Laying Birds

C 1434 Mary LaFlamme Vol#: 34

C 1435 A H Grant Vol#: 34

C 1436 Robyne L Harrington Vol#: 34

C 1437 Thomas Sousa Vol#: 34

C 1438 Barbara Bonsignore Vol#: 34

C 1439 Aleithia Artemis Vol#: 34

C 1440 Stephanie A Romano Vol#: 34

C 1441 Elsie G Fowler Vol#: 34

C 1442 Joe Fisch Vol#: 34

C 1443 Bernadette Sonefeld Vol#: 34

C 1444 Ms Bobbie Harms Vol#: 34

C 1445 Jennifer Downing Vol#: 34

C 1446 Heather E Burns Vol#: 34

C 1447 Eleanora M Worth Vol#: 34

C 1448 Cindy J Hulstine Vol#: 34

C 1449 Nancy Meneely Vol#: 34

C 1450 Monica Gfrorer Vol#: 34

C 1451 Harry Schaeffer Vol#: 34

C 1452 Anne & Christopher Thulin Vol#: 34

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

ANS 6 HFW-14 Vol#: 18

ANS 7 HFW-14 Vol#: 18

ANS 8 HFW-14 Vol#: 18

ANS 9 HFW-14 Vol#: 18

ANS 10 HFW-14 Vol#: 18

ANS 11 HFW-14 Vol#: 18

ANS 12 HFW-14 Vol#: 18

ANS 13 HFW-14 Vol#: 18

ANS 14 HFW-14 Vol#: 18

ANS 15 HFW-14 Vol#: 18

ANS 16 HFW-14 Vol#: 18

ANS 17 HFW-14 Vol#: 18

ANS 18 HFW-14 Vol#: 18

ANS 19 HFW-14 Vol#: 18

ANS 20 HFW-14 Vol#: 18

C 254 Texas Department of Health Vol#: 18

C 255 Eric Nelson Vol#: 18

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98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 107 Imogene DeSmet PhD Vol#: 3

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99D-1089 Year 2000 (Y2K) Compliance Guide; Guidance for FDA Personnel

GDL 1 Vol#: 1

NAD 1 Vol#: 1

99H-0689 Civil Money Penalty; Hugo Okonogi d/b/a Dark Side

CS 1 HFA-305 Vol#: 1

OR 1 HF-3 Vol#: 1

99H-0986 Civil Money Penalties;Charles Harrington,d/b/a 7-Eleven

ANS 1 Charles Harrington,d/b/a 7-Eleven Vol#: 1

99N-0386 Talking with Stakeholders About FDA Modernization

SUM 1 Summary for CDER Vol#: 2

99N-1220 Draft Civil Money Penalty Reduction Policy for Small Entitie

N 1 Vol#: 1

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99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 73 P. Barnhart Vol#: 1

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99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 374 Heather E Burns Vol#: 4

C 375 Robert & Nancy Schoonover Vol#: 4

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99P-1516 To Ban Reprocessed Single Use Devices

ACK 1 HFA-305 Vol#: 1

CP 1 Medical Device Manufacturers Association Vol#: 1

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