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DOCKETS ENTERED on October 24, 2001

TABLE OF CONTENTS

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80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use *
97P-0329 Require Quantitative Labeling of Caffeine Content *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0504 Raw Molluscan Shellfish of Undetectable Levels *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1411 Set a regulatory limit for methylmercury in seafood *
01D-0224 Mass Spectrometry for Confirmation of Identity of Animal Dru *
01D-0297 Avail. of Info Given to Advisory Committee Members CDRH *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0148 Misbranding of reprocessed single use medical devices *
01P-0345 Listing the color additive yellow #5 for use in food/Drug *
01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II *
01Q-0313 Health Claim Petition for Soluble Fiber from Oatrim *
80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use

LET 10 HFD-001 to Oakhurst Co. Vol#: 8

97P-0329 Require Quantitative Labeling of Caffeine Content

C 242 R Whalen Vol#: 4

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

C 5234 T Chen Vol#: 180

C 5235 L Zucker Vol#: 180

C 5236 S Berens Vol#: 180

C 5237 P Sabatini Vol#: 180

C 5238 M Schmidt Vol#: 180

C 5239 R Jacobson Vol#: 180

C 5240 M Porteus Vol#: 180

C 5241 L Patotzka Vol#: 180

C 5242 L Johnsen Vol#: 180

C 5243 V Antman Vol#: 180

C 5244 R Flygar Vol#: 180

C 5245 N Caplan Vol#: 180

C 5246 L Siegel Vol#: 180

C 5247 D Arancio Vol#: 180

C 5248 M Sankari Vol#: 180

C 5249 S Prolman Vol#: 180

C 5250 K Belkin Vol#: 180

C 5251 J Luna Vol#: 180

C 5252 W Brannon Vol#: 180

C 5253 A Bitting Vol#: 180

C 5254 Farm Sanctuary Vol#: 180

C 5255 M Sulla Vol#: 180

EMC 2452 D Outly Vol#: 187

EMC 2453 M Keefer Vol#: 187

EMC 2454 K Parker Vol#: 187

EMC 2455 C Camporeale Vol#: 187

EMC 2456 L Zajac Vol#: 187

EMC 2457 D Gray Vol#: 187

EMC 2458 M Giuliano Vol#: 188

EMC 2459 J Olson Vol#: 188

EMC 2460 C Gann Vol#: 188

EMC 2461 J McConnell Vol#: 188

EMC 2462 J Allen Vol#: 188

EMC 2463 T Dalton Vol#: 188

EMC 2464 M Palacios Vol#: 188

EMC 2465 E Wright Vol#: 188

EMC 2466 C Mekow Vol#: 188

EMC 2467 R Fralick Vol#: 188

EMC 2468 P Chambers Vol#: 188

EMC 2469 D Kitchen Vol#: 188

EMC 2470 L Schwartz Vol#: 188

EMC 2471 D Platt Vol#: 188

EMC 2472 K Bartell Vol#: 188

EMC 2473 H Glick Vol#: 188

EMC 2474 D Leo Vol#: 188

EMC 2475 J Hoban Vol#: 188

EMC 2476 K Krone Vol#: 188

EMC 2477 E Long Vol#: 188

EMC 2478 D Storm Vol#: 188

EMC 2479 M Cram Vol#: 188

EMC 2480 J Hillman Vol#: 188

EMC 2481 C Keith Vol#: 188

EMC 2482 E Hanson Vol#: 188

EMC 2483 T Powers Vol#: 188

EMC 2484 E Jones Vol#: 188

EMC 2485 B Imam Vol#: 188

EMC 2486 S Szehner Vol#: 188

EMC 2487 J Jones Vol#: 188

EMC 2488 M Schuelke Vol#: 188

EMC 2489 C Monachelli Vol#: 188

EMC 2490 M Rangel Vol#: 188

EMC 2491 S Silverhardt Vol#: 188

EMC 2492 C Warn Vol#: 188

EMC 2493 T Allen Vol#: 188

EMC 2494 B Wilson Vol#: 188

EMC 2495 J Soto Vol#: 188

EMC 2496 T Sturm Vol#: 188

EMC 2497 A Schulgasser Vol#: 188

EMC 2498 P Scholl Vol#: 188

EMC 2499 S Miller Vol#: 188

EMC 2500 K Bellairs Vol#: 188

EMC 2501 E Spencer Vol#: 188

EMC 2502 A Brasor Vol#: 188

EMC 2503 D Swaim Vol#: 188

EMC 2504 M Santos Vol#: 188

EMC 2505 T Brown Vol#: 188

EMC 2506 J Schemelia Vol#: 188

EMC 2507 R Varga-Fuller Vol#: 188

EMC 2508 Number not used Vol#: 188

EMC 2509 M Watson Vol#: 188

EMC 2510 Form letters count 1 Vol#: 189

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

EMC 49 A Reycraft Vol#: 28

EMC 50 J Ortiz Vol#: 28

EMC 51 W Hosford Vol#: 28

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

EMC 3451 N Gavin Vol#: 505

00D-1598 Voluntary Labeling for Bioengineered Foods

C 9543 K Keppen Vol#: 476

C 9544 G Hargrave Vol#: 476

C 9545 L Oberg Vol#: 476

C 9546 S Lite Vol#: 476

C 9547 S Kaymen Vol#: 476

EMC 11841 D Weinstein Vol#: 426

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

C 27 California Farmers Union Vol#: 2

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

RPT 1 HFS-830 (Re: Australia New Zealand Food Authority Report) Vol#: 13

00P-1276 Health Claim: Plant stanol esters and heart disease

RPT 1 HFS-830 (Re: Australia New Zealand Food Authority Report) Vol#: 16

00P-1322 Food Labeling and Allergen Contamination Control

C 460 M Thorpe Vol#: 28

C 461 S Meyer Vol#: 28

EMC 430 M Laman Vol#: 20

EMC 431 J Holland Vol#: 20

EMC 432 M Kousidis Vol#: 20

EMC 433 K Ansel Vol#: 20

EMC 434 L. Mazzaferro Vol#: 20

EMC 435 G Mazzaferro Vol#: 20

EMC 436 V Mascia Vol#: 20

EMC 437 G Mazzaferro Vol#: 20

00P-1411 Set a regulatory limit for methylmercury in seafood

EMC 90 K Rodriguez Vol#: 1

EMC 91 K Rodriguez Vol#: 1

EMC 92 A Reycraft Vol#: 1

EMC 93 A Reycraft Vol#: 1

EMC 94 S Kabakian Vol#: 1

EMC 95 S Kabakian Vol#: 1

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

C 184 M Cerulli Vol#: 5

01D-0224 Mass Spectrometry for Confirmation of Identity of Animal Dru

EMC 1 N Weber Vol#: 1

01D-0297 Avail. of Info Given to Advisory Committee Members CDRH

C 6 Advanced Medical Technology Assn Vol#: 1

01H-0065 Civil Money Penalty for First Check Home Drug Test Devices

CS 8 HFA-305 Vol#: 1

OR 7 HF-3 Vol#: 1

01N-0397 Transportation Safety & Potentially Sedating or Impairing

C 3 W Jeffery Vol#: 1

CV 9 A Parmet Vol#: 1

EAPE5 Washington Drug Letter Vol#: 1

EAPE6 Merck Research Laboratories Vol#: 1

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

APE 19 Food Animal Concerns Trust Vol#: 2

APE 20 Virginia Tech Vol#: 2

APE 21 H.J. Baker & Brothers, Inc. Vol#: 2

C 1 J Kirkpatrick Vol#: 1

C 2 Midland BioProducts Corporation Vol#: 1

C 3 K Christopherson Vol#: 1

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

EMC 293 M Hartley Vol#: 10

01P-0148 Misbranding of reprocessed single use medical devices

PDN 1 HFZ-001 to Assn of Disposable Device (AD Vol#: 1

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

EMC 766 P Gatz Vol#: 4

EMC 767 M Davidson Vol#: 4

EMC 768 B Cribbs Vol#: 4

EMC 769 A Campbell Vol#: 4

EMC 770 R Elliott Vol#: 4

EMC 771 C Geden Vol#: 4

EMC 772 D Rourke Vol#: 4

EMC 773 D Steinke Vol#: 4

EMC 774 No signature Vol#: 4

EMC 775 M Russel Vol#: 4

01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II

EMC 1 E Blackburn Vol#: 1

EMC 2 P Mead Vol#: 1

EMC 3 N O'Neill Vol#: 1

EMC 4 J Trotman Vol#: 1

EMC 5 C Hoare Vol#: 1

EMC 6 K Hubbell Vol#: 1

EMC 7 Robert Vol#: 1

EMC 8 K Cradit Vol#: 1

EMC 9 G Grijalva Vol#: 1

EMC 10 S Tact Vol#: 1

01Q-0313 Health Claim Petition for Soluble Fiber from Oatrim

LET 3 The Quaker Oats Company Vol#: 4