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 October 02, 2002

TABLE OF CONTENTS

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81N-0033 Oral Health Care Drug Products for OTC Human Use *
00P-1668 Action against mfrs&dists of garlic supplements misbranded *
01D-0064 Encapsulated Amalgam,Amalgam Alloy & Dental Mercury Labeling *
01N-0067 Reclassification of Dental Mercury *
01P-0120 Ban Unsafe IV Catheters and other Devices *
02P-0033 Carbidopa & Levodopa Orally Disintegrating Tablets *
02P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products *
02P-0292 Health Claims: Walnuts & Cornary Disease *

80N-0042 Anticaries Drug Products for OTC Human Use

C 113 Andrea Sarandes Vol#: 36

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

MM 8 HFD-560 & CHPA Vol#: 70

88V-0165 Variance re Laser light show projector (LIP-88-1)

VRA 7 HFZ-330 to Laser Image Productions Vol#: 1

92V-0118 Variance Request for Laser Light Show

VRA 5 HFZ-300 to San Antonio Theme Park, L.P. Vol#: 1

97N-0511 Procedures the safe and sanitary processing/importing juice

EMC 54 Michael Graham Vol#: 31

98P-0610 Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

EMC 76 Judy McMahill Vol#: 4

98V-0033 Laser light show for LM single scan projection system (LM 10

VRA 3 HFZ-300 to Osmond Family Theater, Ltd. Vol#: 1

99F-4372 National Fisheries Institute and the Louisiana Dep of Agricu

EMC 360 Sharon E. Ciri Vol#: 5

EMC 361 J. Roberts Vol#: 5

EMC 362 Eric Jaimes Vol#: 5

EMC 363 Magdalena Jaimes Vol#: 5

EMC 364 Maureen Jaimes Vol#: 5

EMC 365 Jeff McDermott Vol#: 5

EMC 366 Emily Joseph Vol#: 5

99F-5321 Food Safety & Inspection service safe use of ionizing radiai

EMC 266 Magdalena Jaimes Vol#: 5

EMC 267 Maureen Jaimes Vol#: 5

EMC 268 Jeff McDermott Vol#: 5

EMC 269 Emily Joseph Vol#: 5

99F-5322 Ionizing Radiation for the Treatment of Food

EMC 265 Magdalena Jaimes Vol#: 4

EMC 266 Maureen Jaimes Vol#: 4

EMC 267 Jeff McDermott Vol#: 4

EMC 268 Emily Joseph Vol#: 4

99F-5522 Ionizing radiation /control of Food-borne pathogens safe use

EMC 268 Magdalena Jaimes Vol#: 4

EMC 269 Maureen Jaimes Vol#: 4

EMC 270 Jeff McDermott Vol#: 4

EMC 271 Emily Joseph Vol#: 4

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

EMC 3735 Maureen Jaimes Vol#: 512

EMC 3736 Jeff McDermott Vol#: 512

EMC 3737 Emily Joseph Vol#: 512

99P-4613 Revoke the Regulation That Approved Posilac

C 1389 Kevin M. Crupi Vol#: 44

C 1390 Edward J. Blotzer, Jr. Vol#: 44

C 1391 Dorothy Ramsaier Vol#: 44

C 1392 Gregory J. Healey, M.D., CCFP Vol#: 44

C 1393 Phylis Floyd Vol#: 44

C 1394 Anna L. Moretto Vol#: 44

C 1395 Gisela Ritter Gall Vol#: 44

C 1396 Heather E. Burns Vol#: 44

C 1397 Dorothea S. Goetz Vol#: 44

C 1398 Mr. & Mrs. J. L. Denison Vol#: 44

C 1399 Ann Worrell Vol#: 44

C 1400 Mrs. Robert Anderson Vol#: 44

C 1401 Mare O. Vol#: 44

C 1402 Mr. William Ross Vol#: 44

C 1403 Mr. & Mrs. R. Klinkenberg Vol#: 44

C 1404 Barbara Keenan Vol#: 44

C 1405 Dr. Sandra Ben-Zeers Vol#: 44

C 1406 Franne Sippel-Wetmore Vol#: 44

C 1407 Ronni Weiss Vol#: 44

C 1408 Mary & S. Sauer Vol#: 44

C 1409 Lois A. Klingeman Vol#: 44

C 1410 Roger Van Dyke Vol#: 44

C 1411 Gloria Mack Vol#: 44

C 1412 Ira M. Callan Vol#: 44

C 1413 Miss Margaret Mc Ginnis Vol#: 44

C 1414 Mr. Sam Calaby Vol#: 44

C 1415 Elizabeth Palleseen Vol#: 44

C 1416 Mrs. Susan N. Wijdenes Vol#: 44

C 1417 Elizabeth F. Moody Vol#: 44

C 1418 Patricia Cachopo Vol#: 44

C 1419 Alice M. McTague Vol#: 44

C 1420 Lyn Rosen Vol#: 44

C 1421 Marilyn Evenson Vol#: 44

C 1422 Florette Laiche Vol#: 44

C 1423 Val Colletti Vol#: 44

99P-5106 Identify Sources of Natural Flavorings

EMC 142 Bill Chase Vol#: 2

99V-0555 Laser images dual RGB projector

VRA 2 HFZ-300 to The Cook Arts, Science & Tech Vol#: 1

00P-1668 Action against mfrs&dists of garlic supplements misbranded

PDN 1 HFC-200 to CSPI Vol#: 1

01D-0064 Encapsulated Amalgam,Amalgam Alloy & Dental Mercury Labeling

C 2 Sandra Duffy, J.D. Vol#: 2

C 3 Maine DEP Vol#: 1

C 4 Consumers for Dental Chocie, Inc. Vol#: 1

C 5 Consumers for Dental Chocie, Inc. Vol#: 1

01F-0047 Foodborne pathogens in raw-frozen-cooked-partially cooked

EMC 365 Magdalena Jaimes Vol#: 6

EMC 366 Maureen Jaimes Vol#: 6

EMC 367 Jeff McDermott Vol#: 6

EMC 368 Emily Joseph Vol#: 6

01N-0067 Reclassification of Dental Mercury

C 90 Sandra Duffy, J.D. Vol#: 14

C 91 Elizabeth Hopp Vol#: 15

C 92 Arthur L. Koch, D.O. Vol#: 15

C 93 Holistic Dental Assn Vol#: 15

C 94 Senator Michael H. Michaud Vol#: 15

C 95 Donald Winter Vol#: 15

C 96 Dolly Marshall Vol#: 15

C 97 Lindell Tinsley Vol#: 15

C 98 Lindell Tinsley Vol#: 15

C 99 Michael S. Shaw Vol#: 15

C 100 Susan Jannarone Vol#: 15

C 101 Marie Flowers Vol#: 15

C 102 Marie Flowers Vol#: 15

C 103 Assemblyman Dick Dickerson Vol#: 15

C 104 Jennifer Gosse Vol#: 15

C 105 Patti Ayers et al. Vol#: 15

C 106 Tammy Slater-McCoy Vol#: 15

C 107 Marie Flowers Vol#: 15

C 108 Consumers for Dental Choice, Inc. Vol#: 15

C 109 Consumers for Dental Choice, Inc. Vol#: 15

EMC 622 Marilyn Brown Vol#: 10

EMC 623 Mary Ann Newell Vol#: 10

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

EMC 3 Cynthia Thomason Vol#: 3

01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC

EMC 299 Karen Paulie Vol#: 10

EMC 300 No signature Vol#: 10

01P-0120 Ban Unsafe IV Catheters and other Devices

C 29 Bioject, Inc. Vol#: 3

C 30 American Society of Anesthesiology (ASA) Vol#: 3

01P-0345 Listing the color additive yellow #5 for use in food/Drug

EMC 1123 Trudy Wruck Vol#: 5

EMC 1124 Cara E. O'Callaghan Vol#: 5

EMC 1125 No signature Vol#: 5

02P-0033 Carbidopa & Levodopa Orally Disintegrating Tablets

PAV 1 HFD-600 to Lachman Consultant Services Vol#: 1

02P-0059 Refrain from Approving ANDA for Isotretinoin Drug Products

LET 2 Hoffmann-La Roche Inc. Vol#: 1

02P-0292 Health Claims: Walnuts & Cornary Disease

C 2 Liz Weiss, M.S., R.D. Vol#: 6

C 3 California Walnut Commission Vol#: 6

C 4 Healthsouth Heart College Vol#: 6

C 5 Kenneth I. Burke, PhD, RD Vol#: 6

C 6 Loma Linda University Vol#: 6

C 7 Frank B. Hu, MD, PhD Vol#: 6

C 8 Edward Colt, MD, FACP, FRCP Vol#: 6

02P-0317 Recall Aspartame as a Neurotoxic Drug

EMC 21 Joan H. Edge Vol#: 1

EMC 22 Soroush Ebrahimi Vol#: 1

EMC 23 Norma Flores Vol#: 1

EMC 24 Norma Flores Vol#: 1

EMC 25 Xaviera Wilson Vol#: 1

EMC 26 Norma Flores Vol#: 1

EMC 27 Myra Mitchell Vol#: 1

EMC 28 Sandra Miller Vol#: 1

EMC 29 Linda A. Krueger Vol#: 1

02V-0202 Laser Light Show and Projector

VRA 1 HFZ-300 to Digital Jamz Vol#: 1

02V-0239 Laser Light Show

VRA 1 HFZ-300 to Spellbound Productions Vol#: 1

02V-0334

VRA 1 HFZ-300 to Solavanti, L.L.C. DBA Contour Vol#: 1

02V-0356 Laser light show

VRA 1 HFZ-300 to 50 Liberty Pole Way, Inc. dba Vol#: 1

02V-0432 Variance for Laser Triangulation Measurement System

ACK 1 HFA-305 to IVP Integrated Vision Product Vol#: 1

VAR 1 IVP Integrated Vision Products AB Vol#: 1

02V-0433 Laser light show

ACK 1 HFA-305 Vol#: 1

VAR 1 Radio Interactive Vol#: 1