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 January 30, 2001

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants *
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use *
81N-0022 OTC Weight Control Drug Products for Human Use *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1631 Genotoxicity Studies (VICH GL23) *
00D-1632 Management of Adverse Event Reports (AER's) (VICH GL24) *
00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals *
00N-1520 Labeling of Menstrual Tampons: Ranges of Absorbency *
00N-1571 Enrofloxacin for Poultry: Opportunity for hearing *
00N-1604 Test Sample Collection Systems for Drugs of Abuse Testing *
00P-1210 Restrict Sale of Coal Tar-Containing Products *
00P-1554 Exempt pharmacy compounding systems/Class II devices from PM *
00P-1607 Revoke Implantation of Silicone Gel-Filled Breast Implants *

76N-052N OTC Nasal Decongestants

EMC 94 C Dugger Vol#: 76

EMC 95 S Wilson Vol#: 76

EMC 96 Sinai Samaritan Medical Center Vol#: 76

EMC 97 McDonald & Kanyuk, PLLC Vol#: 76

EMC 98 W. Barger Vol#: 76

EMC 99 S Gore Vol#: 76

LET 120 HFD-1 to Public Citizen Hlth Res. Group Vol#: 76

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

MT 14 HFD-560 & Block Drug Company Vol#: 235

80N-0146 Nailbiting & Thumbsucking Deterrent Drug Product for OTC Use

ACK 1 HFA-305 Vol#: 8

PRC 1 McKenna & Cuneo/behalf of Oakhurst Co Vol#: 8

81N-0022 OTC Weight Control Drug Products for Human Use

LET 114 HFD-1 to Public Citizen Hlth Research Gr Vol#: 95

96M-0311 Guideline on Infectious Disease Issues in Xenotransplantatio

GDL 2 Guideline Vol#: 20

NAD 2 Vol#: 20

98D-0545 Recommendations/Collecting Red Blood Cells/Auto. Apheresis

GDL 2 Guideline Vol#: 1

NAD 2 Vol#: 1

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

C 3436 H Despasquale Vol#: 109

C 3437 R. E. Lopresto Vol#: 109

C 3438 L Dixon Vol#: 109

C 3439 D Cora Vol#: 109

C 3440 J. Hall Vol#: 109

C 3441 K Gee Vol#: 109

C 3442 Y Rosen Vol#: 109

C 3443 R Higgins Vol#: 109

C 3444 J. Steward Vol#: 109

C 3445 V. Soule Vol#: 109

C 3446 S. Palazzolo Vol#: 109

C 3447 P Ide Vol#: 109

C 3448 A Chavez Vol#: 109

C 3449 C Coughler Vol#: 109

C 3450 J Lauren Vol#: 109

C 3451 S McGee Vol#: 109

C 3452 L Lahalih Vol#: 109

C 3453 K Kovach Vol#: 110

C 3454 Rev. Price Vol#: 110

C 3455 M Love Vol#: 110

C 3456 J Crites Vol#: 110

C 3457 M Papa Vol#: 110

C 3458 M. Heinemann Vol#: 110

C 3459 B. Wilkinson Vol#: 110

C 3460 A. Brandofsky Vol#: 110

C 3461 M Treat Vol#: 110

C 3462 M Niles Vol#: 110

C 3463 E Herman Vol#: 110

C 3464 S Boom Vol#: 110

C 3465 E Oladian Vol#: 110

C 3466 P Roth Vol#: 110

C 3467 V. Collins Vol#: 110

C 3468 E Pettey Vol#: 110

EMC 652 C Reynolds Vol#: 109

EMC 653 D Brown Vol#: 109

EMC 654 L Gentille Vol#: 109

EMC 655 J Borodin Vol#: 109

EMC 656 G McMahon Vol#: 109

EMC 657 B Laurer Vol#: 109

EMC 658 R Sanders Vol#: 109

EMC 659 E Cappelletti Vol#: 109

EMC 660 D Brandon Vol#: 109

EMC 661 D. Ghantt Vol#: 109

EMC 662 S Figueroa Vol#: 109

EMC 663 K Davis. Vol#: 109

EMC 664 B Laudan Vol#: 109

EMC 665 T Jordan Vol#: 109

EMC 666 A Sacilowski Vol#: 109

EMC 667 R Updyke Vol#: 109

EMC 668 J Gonska Vol#: 109

EMC 669 P. Carmichael Vol#: 109

EMC 670 M. Giese Vol#: 109

EMC 671 N Litvack Vol#: 109

EMC 672 R DelRey Vol#: 109

EMC 673 C Morris Vol#: 109

EMC 674 S Gross. Vol#: 109

EMC 675 M Magdinec Vol#: 109

EMC 676 H Morris Vol#: 109

EMC 677 T David Vol#: 109

EMC 678 S Matthews Vol#: 109

EMC 679 K O'Brien Vol#: 109

EMC 680 R Gramalia Vol#: 109

EMC 681 J Moretti Vol#: 109

EMC 682 R Landau Vol#: 109

EMC 683 L Trotta Vol#: 109

EMC 684 J Ross Vol#: 109

EMC 685 M. Medina Vol#: 109

EMC 686 K Kurrus Vol#: 109

EMC 687 F Perlman Vol#: 109

EMC 688 P Kimball Vol#: 109

EMC 689 B Robinson Vol#: 109

EMC 690 E Willberg Vol#: 109

EMC 691 W Johnson. Vol#: 109

EMC 692 L Schoenberg Vol#: 109

EMC 693 J Isaac Vol#: 109

EMC 694 R Javier Vol#: 109

EMC 695 K. Smith Vol#: 109

EMC 696 R Danta Vol#: 109

EMC 697 M McIntosh Vol#: 109

EMC 698 N Winters Vol#: 110

EMC 699 Advocates for Animals Vol#: 110

EMC 700 J Wurth Vol#: 110

EMC 701 R Lagodka Vol#: 110

EMC 702 T Scott Vol#: 110

EMC 703 C Bailey Vol#: 110

EMC 704 E Bohacek Vol#: 110

EMC 705 W Lochner Vol#: 110

EMC 706 Myrafromtx Vol#: 110

EMC 707 E. Anderson Vol#: 110

EMC 708 M Carmichael Vol#: 110

EMC 709 C. Peitzmeyer Vol#: 110

EMC 710 K Ewell Vol#: 110

EMC 711 L Friedberg Vol#: 110

EMC 712 Pig Lib Vol#: 110

EMC 713 J Stone Vol#: 110

EMC 714 L Schad Vol#: 110

EMC 715 C Parrett Vol#: 110

EMC 716 N Rotussney Vol#: 110

EMC 717 T Guerra Vol#: 110

EMC 718 J Luptak Vol#: 110

EMC 719 Ocean522 Vol#: 110

EMC 720 L Hollings Vol#: 110

EMC 721 C Hillwig Vol#: 110

99N-1075 Vibrio Parahaemolyticus in molluscan shellfish public health

BKG 3 BACKGROUND Vol#: 5

00D-1598 Voluntary Labeling for Bioengineered Foods

C 1 J Walters Vol#: 5

C 2 R Noll Vol#: 5

C 3 L Anderson Vol#: 5

C 4 H. Heiner Vol#: 5

C 5 F.F. Rodgers Vol#: 5

C 6 H Noyer Vol#: 5

C 7 A Strombom Vol#: 5

C 8 S Wiggs Vol#: 5

C 9 S. Shaw Vol#: 5

C 10 B Shaw Vol#: 5

C 11 R Zeltner Vol#: 5

C 12 J Audoire Vol#: 5

C 13 J. Farrar Vol#: 5

C 14 K Milstein Vol#: 5

C 15 M Hoffman Vol#: 5

C 16 L. Casten Vol#: 5

C 17 L. Umlanf Vol#: 5

C 18 American Association of Bovine Practitis Vol#: 5

C 19 M Haas Vol#: 5

C 20 D Haas Vol#: 5

C 21 B Haas Vol#: 5

C 22 S Turvey Vol#: 5

C 23 W Murphy Vol#: 5

C 24 T Robertson Vol#: 5

C 25 H Whisman Vol#: 5

C 26 R Attemann Vol#: 8

C 27 K Wortman Vol#: 8

C 28 R Adams Vol#: 8

C 29 A Chaiclin Vol#: 8

C 30 W Lill Vol#: 8

C 31 M Stowe Vol#: 8

C 32 Baird Vol#: 8

C 33 J. Clark Vol#: 8

C 34 R. Pierson, Jr Vol#: 8

C 35 L Rassner Vol#: 8

C 36 J Reed Vol#: 8

C 37 R. Stockwell Vol#: 8

C 38 A Haas Vol#: 8

C 39 B Haas Vol#: 8

C 40 W Brennan Vol#: 8

C 41 W Haas Vol#: 8

C 42 S Arndt Vol#: 8

C 43 J. Powers Vol#: 8

C 44 M Bedjai Vol#: 8

C 45 D Lane Vol#: 8

C 46 R. Beardsworth Vol#: 8

C 47 S Mou Vol#: 8

C 48 S. Mou Vol#: 8

C 49 J. Mou Vol#: 8

C 50 T. Mou Vol#: 8

C 51 R Gillen Vol#: 8

C 52 T Beardsley Vol#: 8

C 53 E McPherson Vol#: 8

C 54 L Charlesworth Vol#: 8

C 55 M Blackhorse Vol#: 8

C 56 J. Kurtz Vol#:

C 57 C. Merrill Vol#: 8

C 58 M Bergman Vol#: 8

C 59 M Makrucki Vol#: 8

C 60 D Bergman Vol#: 8

C 61 Harrington Investments, INC. Vol#: 8

C 62 D Marshak Vol#: 8

C 63 J. Maassen Vol#: 8

C 64 K Donald Vol#: 8

C 65 W Drelles Vol#: 8

C 66 B. Jones Vol#: 8

C 67 J Hatch. Vol#: 8

C 68 A. Bush Vol#: 8

C 69 B Fiore Vol#: 8

C 70 O Boothman Vol#: 8

C 71 R. White MD Vol#: 8

C 72 S Van Asch Van Wyck Vol#: 8

C 73 R. Sabella Vol#: 8

C 74 S Marrazzo Vol#: 8

C 75 B McKenney Vol#: 8

C 76 K Tittone Vol#: 8

C 77 R Stenger Vol#: 8

C 78 K. Walker Vol#: 8

C 79 G Weissmann Vol#: 8

C 80 K Eddy Vol#: 8

C 81 R. Johnson Vol#: 8

C 82 C. May Vol#: 8

C 83 G Houk Vol#: 8

C 84 H Noyer Vol#: 8

00D-1631 Genotoxicity Studies (VICH GL23)

C 1 US Environmental Protection Agency Vol#: 1

C 2 Ingle & Traul Pharmaceutical Cnsltg Inc Vol#: 1

MM 1 FDA Gene Tox Network Vol#: 1

00D-1632 Management of Adverse Event Reports (AER's) (VICH GL24)

C 1 American Veterinary Med Assn Vol#: 1

00D-1677 Use of Antimicrobial Drugs in Food-Producing Animals

C 1 Animal Health Institute Vol#: 1

00N-1520 Labeling of Menstrual Tampons: Ranges of Absorbency

C 1 Procter & Gamble Vol#: 1

C 2 Assn of the Nonwoven Frabrics Industry Vol#: 1

00N-1571 Enrofloxacin for Poultry: Opportunity for hearing

C 124 L. Simpson Vol#: 18

C 125 N. Dinges, Jr. Vol#: 18

00N-1604 Test Sample Collection Systems for Drugs of Abuse Testing

C 1 Independent Industry Consultant Vol#: 1

00P-1210 Restrict Sale of Coal Tar-Containing Products

LET 2 HFD-1 to Occupational Knowledge Intl Vol#: 1

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

C 1 Schulman Treem Kaminkow, Gilden & Ravenl Vol#: 1

00P-1607 Revoke Implantation of Silicone Gel-Filled Breast Implants

C 1 M Harbut Vol#: 1

01V-0052 Laser Light Show

ACK 1 HFA-305 Vol#: 1

VAR 1 Utopia Lasers Vol#: 1

01V-0054

VAR 1 Quest Marketing Vol#: 1