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 February 14, 2001

TABLE OF CONTENTS

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97P-0350 Reclassify Home Uterine Activity Monitors from III to II *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
00D-1492 Mutual Recognition Agreement,Medical Device Annex Confidence *
00D-1562 Clinical Data In Marketing Applications *
00D-1563 Industry on Carcinogenicity Study protocol submissions *
00D-1587 Medical Devices Guidance for Prescription Drugs Abuse Assays *
00D-1598 Voluntary Labeling for Bioengineered Foods *
00D-1632 Management of Adverse Event Reports (AER's) (VICH GL24) *
00N-1269 Labeling for human prescription drug/Biologic Products *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00N-1521 Agency Information Collection Act: Food Labeling Regulations *
00N-1545 Proposed Revision of Postmarketing Reporting Requirements *
00N-1666 Abbreviated New Drug Application Regulations; Patent & Exclu *
00N-1669 Electronic filing of drug registration and listing informati *
00N-1686 Electronic INDA cumulative table of contents public meeting *
00P-1352 ANDA Suitability Petition Camiodarone Hydrochloride Injectio *
00P-1365 ANDA be submitted for Fluoxetine Tablets/40 mg *
00P-1419 ANDA for Gabapentin Tablets 100 mg 300 mg and 400 mg *
00P-1470 ANDA 75-880 for 6%and10% PremaSol-sulfite-free (Amino Acid) *
00P-1551 Determine an ANDA may be submitted for a propxphene Napsylat *
00P-1564 Grant a temporary exemption for one packaging component *
00P-1577 Variance from source-skin distance requirement of perf. std. *
00P-1600 ANADA Suitability for Ivermectin *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *

96V-0319 Laser light show

EXP 3 Eastern Kentucky University Vol#: 1

97P-0350 Reclassify Home Uterine Activity Monitors from III to II

AMD 1 HFZ-470 to GE Marquette Medical Systems, Vol#: 5

PAV 1 HFZ-470 to GE Marquette Medical Systems, Vol#: 5

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

C 3824 Malgosia Cegielski, Ph.D. Vol#: 120

C 3825 Lynn F. Wallace Vol#: 120

C 3826 Jan Cejka, Ph.D. Vol#: 120

C 3827 Lori A. Szewczyk Vol#: 120

C 3828 Barb & Joe McCarthy Vol#: 120

C 3829 Lisette C. Weishaupt Vol#: 120

C 3830 Margaret Q. Wehinger Vol#: 120

C 3831 Joseph Bova Vol#: 120

C 3832 Robin Gaye Thrapp Vol#: 120

C 3833 Margaret S. Wells Vol#: 120

C 3834 Dino Vlachos Vol#: 120

C 3835 The H. T. Weston Family Vol#: 120

C 3836 Ms. Evelyn D. Rios V

C 3837 Martha Carrington Vol#: 120

C 3838 Robert J. Langley Vol#: 120

C 3839 N.T. Porter Vol#: 120

C 3840 Pamela Buitrago Vol#: 120

C 3841 Khristi A. Tomlinson Vol#: 120

C 3842 Jacqueline Smith Wagoner Vol#: 120

C 3843 D L. F Vol#: 120

C 3844 Yvonne Ciccone Vol#: 120

C 3845 Maria Weizmann-Jaramillo Vol#: 120

C 3846 Ms. Kerul L. Kassel Vol#: 120

C 3847 Ms. Maryann Kirchenbauer Vol#: 120

C 3848 Rebecca Egbert Vol ol#: 120 #: 120

C 3849 Anne M. Stephany Vol#: 120

C 3850 Michelle Haag Vol#: 120

C 3851 Jo Ann Arcarise Vol#: 120

C 3852 Pamela L. Roudebush Vol#: 120

99N-1168 Public Health Impact of Foodborne Listeria Monocytogenes

EXT 1 LM Working Group Vol#: 1

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

C 16938 Mitch Altman Vol#: 488

C 16939 Robert Lake Vol#: 488

C 16940 Lynda Means Vol#: 488

C 16941 Chris & Gail Ybarzabal Vol#: 488

C 16942 Ventine Hershey Vol#: 488

EMC 3373 Jacquelin Veros Vol#: 488

EMC 3374 Leah Haustman Vol#: 488

EMC 3375 Karen Snarr Vol#: 488

EMC 3376 Joshua Forgotson Vol#: 488

EMC 3377 David L Fritz Vol#: 488

EMC 3378 Kay Stoltz Vol#: 488

EMC 3379 Deborah Schwartz Vol#: 488

EMC 3380 Robin Pavolsky Vol#: 488

EMC 3381 Marlene Weir Vol#: 488

EMC 3382 Amy C Field Vol#: 488

EMC 3383 Leslie Martel Baer Vol#: 488

EMC 3384 Patrick Walz Vol#: 488

EMC 3385 Wanita Hauger Vol#: 488

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2829 James Stanford Vol#: 200

C 2830 Camina Tripodi Vol#: 200

C 2831 Constance C Schulz Vol#: 200

C 2832 Coriene Kelly Vol#: 200

C 2833 Miriam K Dailey Vol#: 200

C 2834 Selma Plotkin Vol#: 200

C 2835 Renee F Cooper Vol#: 200

C 2836 Rita J Bonasera Vol#: 200

C 2837 Elinore Tushner Vol#: 200

C 2838 M D Vol#: 200

C 2839 C M Bell Vol#: 200

C 2840 Warren & Olive Wilson Vol#: 200

C 2841 Lourdes T Sadanaga Vol#: 200

C 2842 Lauren Swain Vol#: 200

C 2843 Gerald G Geci Vol#: 200

C 2844 Marcine D Bendtsen Vol#: 200

C 2845 Jane Desotelle Vol#: 200

C 2846 Alice Pemble Vol#: 200

C 2847 B Y Love Vol#: 200

C 2848 P C Szabo Vol#: 200

C 2849 L Mackel Vol#: 200

C 2850 O Quinone Vol#: 200

C 2851 Phillip H Coe Vol#: 200

C 2852 Ann Rowell Vol#: 200

C 2853 Jessie Gretzinger Vol#: 200

C 2854 Pat Christensen Vol#: 200

C 2855 Virginia Fabilli Vol#: 200

C 2856 Marjorie Williams Vol#: 200

C 2857 Everett Peterson Vol#: 200

C 2858 Mary Evans Vol#: 200

C 2859 Ron Collins Vol#: 200

C 2860 Richard W Lyman Vol#: 200

C 2861 Dorothy Saxe Vol#: 200

C 2862 Janet H Penderass Vol#: 200

C 2863 Charles Safiran Vol#: 200

C 2864 Angela Emery Vol#: 200

C 2865 Judith A Johnsen Vol#: 200

C 2866 George Busse Vol#: 200

C 2867 M Virginia Grady Vol#: 200

EMC 390 L Privitera Vol#: 200

EMC 391 P Prober Vol#: 200

EMC 392 J Servais Vol#: 200

EMC 393 P Cantrell Vol#: 200

EMC 394 G Shotz Vol#: 200

EMC 395 T Ellison Vol#: 200

99V-1272 Laser Light Show-Omniscan Laser Projection System Model 2000

EXP 1 AVI, Imagineering With Lasers Vol#: 1

00D-1492 Mutual Recognition Agreement,Medical Device Annex Confidence

LET 1 Merck Frosst Canada & Co. Vol#: 1

00D-1562 Clinical Data In Marketing Applications

C 6 Genentech Inc Vol#: 1


00D-1563 Industry on Carcinogenicity Study protocol submissions

C 2 Triangle Pharmaceuticals Vol#: 1

C 3 AstraZeneca Pharmaceuticals LP Vol#: 1

C 4 Alza Corp. Vol#: 1

C 5 Merck & Co, Inc. Vol#: 1

C 6 Pharmacia Corp. Vol#: 1

C 7 DuPont Pharmaceuticals Co. Vol#: 1

00D-1587 Medical Devices Guidance for Prescription Drugs Abuse Assays

C 1 Medtox Diagnostic Inc Vol#: 1


00D-1598 Voluntary Labeling for Bioengineered Foods

EC 90 Mr. Bruce Hearle Vol#: 23

EC 91 Ms. Kimberly Smith Vol#: 23

EC 92 Ms. Joane Kulish Vol#: 23

EC 93 Ms. Rebecca Thibault Vol#: 23

EC 94 Ms. Martha Forrester Vol#: 23

EC 95 Mr. Dave Turner Vol#: 23

EC 96 Ms. Tracy Miller Vol#: 23

EC 97 Ms. Lynne Simpson Vol#: 23

EC 98 Ms. Kathy Lake Vol#: 23

EC 99 Mrs. Elise Miller Vol#: 23

EC 100 Ms. Gina Miller Vol#: 23

EC 101 Mr. W. Dean Mindock Vol#: 23

EC 102 Mrs. Cheri Smith Vol#: 23

EC 103 Ms. Ann Myers Vol#: 23

EC 104 Ms. MARTHA Bennett Vol#: 23

EC 105 Ms. Gerianne Carillo Vol#: 23

EC 106 organically grown company Vol#: 23

EC 107 Mrs. Holly Mawby Vol#: 23

EC 108 Mrs. Linda Clevinger Vol#: 23

EC 109 Mr. Craig Weber Vol#: 23

EC 110 Mrs. Lois Hluhan Vol#: 23

EC 111 Ms. Loie Atkinson Vol#: 23

EC 112 Mr. Edund Fladung Vol#: 23

EC 113 Wood Creek Farm Vol#: 23

EC 114 Ms. Micky Komara Vol#: 23

EC 115 Ms. Cindi Cochran Vol#: 23

EC 116 Ms. Anna Dominguez Vol#: 23

EC 117 Mr. Rick Adams Vol#: 23

EC 118 Ms. Donna Quinn Vol#: 23

EC 119 Mr. Mike Torreyson Vol#: 23

EC 120 CTC Solutions Vol#: 23

EC 121 Ms. Cynthia Coachman Vol#: 23

EC 122 Copper River School District Vol#: 23

EC 123 n/a Vol#: 23

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

C 2 Animal Health Inst (AHI) Vol#: 1


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

C 4 Arrowsmith-Lowe Consulting Inc Vol#: 2

EXT 1 Pharmaceutical Research & Manufac(PhRMA) Vol#: 2

00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs

C 25 Luitpold Pharmaceuticals, Inc. Vol#: 2

00N-1396 Bioengineered Foods Consumed By Humans or Animals

EMC 23 C Brownstein Vol#: 9

EMC 24 Y Rousseau Vol#: 9

EMC 25 L Nowicki Vol#: 9

EMC 26 M Brower Vol#: 9

EMC 27 C P Olsen Vol#: 9

EMC 28 S Weiner Vol#: 9

EMC 29 J A Schimpff Vol#: 9

EMC 30 G Davenport Vol#: 9

EMC 31 J Davenport Vol#: 9

EMC 32 L James Vol#: 9

EMC 33 L Jarvis Vol#: 9

EMC 34 M Corsaro Vol#: 9

EMC 35 M Schweder Vol#: 9

EMC 36 Form Letter Count Vol#: 14

EMC 37 W Dee Vol#: 15

EMC 38 K F Hence Vol#: 15

EMC 39 P Espinosa Vol#: 15

EMC 40 K Gewalt Vol#: 15

EMC 41 D Self Vol#: 15

EMC 42 E Hoffner Vol#: 15

EMC 43 A Mizicko Vol#: 15

EMC 44 W Thomas Vol#: 15

EMC 45 P Carr Vol#: 15

EMC 46 P Carey Vol#: 15

EMC 47 J Muehlhauser Vol#: 15

EMC 48 R Whitney Vol#: 15

EMC 49 S Mack Vol#: 15

EMC 50 K Hill Vol#: 15

EMC 51 J Mollett Vol#: 15

EMC 52 T Steely Vol#: 15

EMC 53 D Hoaglin Vol#: 15

EMC 54 D Freeze Vol#: 15

EMC 55 V Chassot Vol#: 15

EMC 56 N Batalion Vol#: 15

EMC 57 Number Not Used Vol#: 15

EMC 58 K Pitts Vol#: 15

EMC 59 S Mitchell Vol#: 15

EMC 60 S Mitchell Vol#: 15

EMC 61 M Steiskal Vol#: 15

EMC 62 J Asher Vol#: 15

EMC 63 W F Wolfe, Jr. Vol#: 15

EMC 64 T Taylor Vol#: 15

EMC 65 J A Swaney, Ph.D. Vol#: 15

EMC 66 M E Riley Vol#: 15

EMC 67 C Mills Vol#: 15

EMC 68 K Manville Vol#: 15

EMC 69 M Schwartz, M.D. Vol#: 15

EMC 70 D Peterson Vol#: 15

EMC 71 L A James Vol#: 15

EMC 72 D Kuppinger Vol#: 15

EMC 73 K Isaacson Vol#: 15

EMC 74 G Smith Vol#: 15

EMC 75 L Antrim Vol#: 15

EMC 76 A Conry Vol#: 15

EMC 77 C T Deupree Vol#: 15

EMC 78 L Davis Vol#: 15

EMC 79 S Kieny Vol#: 15

EMC 80 D Dee Vol#: 15

EMC 81 K Fisher Vol#: 15

EMC 82 P Snouffer, RN, BSN Vol#: 15

EMC 83 K Munson Vol#: 15

EMC 84 T Parker Vol#: 15

EMC 85 H Mitchell Vol#: 15

EMC 86 J Herbert Vol#: 15

EMC 87 T Hall Vol#: 15

EMC 88 P Bennett Vol#: 15

EMC 89 J Kimble Vol#: 15

EMC 90 B Harper-McIntosh Vol#: 15

EMC 91 D Quilter Vol#: 15

EMC 92 P H Coe Vol#: 15

00N-1521 Agency Information Collection Act: Food Labeling Regulations

C 1 Avram Lyon Vol#: 1


00N-1545 Proposed Revision of Postmarketing Reporting Requirements

C 2 Aventis Pharmaceuticals Vol#: 1

C 3 AstraZeneca Pharmaceuticals LP Vol#: 1

C 4 Merck & Co, Inc. Vol#: 1

00N-1666 Abbreviated New Drug Application Regulations; Patent & Exclu

EC 3 Mr. Larry Shepherd Vol#: 1

00N-1669 Electronic filing of drug registration and listing informati

LET 30 Amide Pharmaceutical Inc Vol#: 1

LET 31 Procter & Gamble Co Vol#: 1

LET 32 McNeil Consumer Healthcare Vol#: 1

LET 33 Pharmaceutical Research Inst Vol#: 1

LET 34 Solvay Pharcaceuticals Inc Vol#: 1

LET 35 Gensia Sicor Pharcaceuticals Inc Vol#: 1

LET 36 Baxter Healthcare Corp Vol#: 1

00N-1686 Electronic INDA cumulative table of contents public meeting

C 1 Mojo Commerce LLC Vol#: 1


00P-1352 ANDA Suitability Petition Camiodarone Hydrochloride Injectio

PAV 1 HFD-600 TO GensiaSicor Pharmaceuticals Vol#: 1


00P-1365 ANDA be submitted for Fluoxetine Tablets/40 mg

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


00P-1419 ANDA for Gabapentin Tablets 100 mg 300 mg and 400 mg

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


00P-1470 ANDA 75-880 for 6%and10% PremaSol-sulfite-free (Amino Acid)

PAV 1 HFD-600 to Baxter Healthcare Corporation Vol#: 1

00P-1551 Determine an ANDA may be submitted for a propxphene Napsylat

PAV 1 HFD-600 to Arnall Golden & Gregory, LLP Vol#: 1


00P-1564 Grant a temporary exemption for one packaging component

WDL 1 Alcon Research LTD. Vol#: 1


00P-1577 Variance from source-skin distance requirement of perf. std.

PAV 1 HFZ-340 to GE OEC Medical Systems, Inc. Vol#: 1


00P-1600 ANADA Suitability for Ivermectin

LET 1 Royer Biomedical, Inc. Vol#: 1

LET 2 Royer Biomedical, Inc. Vol#: 1

01M-0072 PMA Pro-Trac II Tacrolimus ELISA Kit, P970025

AAV 1 Diasorin Inc Vol#: 1

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

ACK 1 HFA-305 Vol#: 1

CP 1 The Ctr for Reproductive Law & Policy Vol#: 1