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 October 19, 2001

TABLE OF CONTENTS

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97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD *
99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices *
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-5198 Request amendment of the definition of milk *
00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz *
00P-1322 Food Labeling and Allergen Contamination Control *
00P-1550 Approve ANDA for Cefuroxime Axetil Products *
01D-0269 Clinical Studies Section for Prescription Drugs & Biologics *
01D-0286 In Vitro HIV Drug Resistance Genotype Assays [510(k)s] *
01D-0297 Avail. of Info Given to Advisory Committee Members CDRH *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01N-0402 Third-Party Submissions review/quality system inspections *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01P-0075 Switch Status of Emergency Contraceptives from Rx to OTC *
01P-0150 Salad Dressing Deviating *
01P-0230 Domestic Marketing & Importation of Transgenic Fish *
01P-0345 Listing the color additive yellow #5 for use in food/Drug *
01P-0428 Generic Cefuroxime Axetil Products *

85V-0340 Laser media model LMS

VRA 6 HFZ-340 to Peachtree Laser Inc. Vol#: 1

95V-0327 Laser Light Show

VRA 3 HFZ-340 to Laser X Vol#: 1

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

C 27 European Plasma Fractionation Assn Vol#: 1

98V-0198 Laser Light Show

VRA 2 HFZ-340 to Ballingers USA, Inc. d/b/a We Vol#: 1

99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices

EC 5 Gardiner Community Health Center Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

C 733 Sharon Vanderboon Vol#: 18

99P-5198 Request amendment of the definition of milk

ANS 1 HF-40 to National Farmers Union Vol#: 1

C 1 National Farmers Union Vol#: 1

00D-0186 M4 Common Technical Document;InterNatl Confern on Harmonisat

GDL 3 Guidance Vol#: 3

GDL 4 GUIDANCE Vol#: 3

GDL 5 GUIDANCE Vol#: 3

GDL 6 GUIDANCE Vol#: 3

NAD 3 Vol#: 3

00E-1250 Patent Extension Synercid #4,798,827

NCR 1 Vol#: 1

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

ANS 1 HF-40 to National Farmers Union Vol#: 2

00P-1322 Food Labeling and Allergen Contamination Control

EC 12 Broward County Dietetic Association Vol#: 17

EC 13 Mrs. Linda Bender Vol#: 17

EC 14 N/A Vol#: 17

00P-1550 Approve ANDA for Cefuroxime Axetil Products

C 1 Arnold & Porter Vol#: 2

01D-0269 Clinical Studies Section for Prescription Drugs & Biologics

C 2 Merck & Co, Inc. Vol#: 1

01D-0286 In Vitro HIV Drug Resistance Genotype Assays [510(k)s]

C 3 Visible Genetics Inc. Vol#: 1

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

C 4 Abbott Laboratories Vol#: 1

C 5 Steven Rohr Vol#: 1

01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA

WDL 1 KV Pharmaceutical Company Vol#: 1

01N-0266 Medical Device Registration and Listing

N 2 Vol#: 1

01N-0267 Agency Information Collection: Medical Device Labeling Reg

N 2 Vol#: 1

01N-0397 Transportation Safety & Potentially Sedating or Impairing

C 1 Natalie P. Hartenbaum, MD, MPH Vol#: 1

C 2 Dr. J.J. de Gier Vol#: 1

01N-0402 Third-Party Submissions review/quality system inspections

EC 1 SELF GAY ADVOCATE Vol#: 1

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

APE 10 Fats & Proteins Reseach Foundation, Inc. Vol#: 2

APE 11 American Proteins, inc. Vol#: 2

EC 1 Ms. Barbara Sachau Vol#: 4

01N-0437 New Animal Drugs for Investigational

N 1 Vol#: 1

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

C 235 Kathryn Anthony Vol#: 10

01P-0150 Salad Dressing Deviating

SUP 1 Kraft Foods Vol#: 1

01P-0230 Domestic Marketing & Importation of Transgenic Fish

C 217 Peter Dexheimer Vol#: 23

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

EMC 703 Harley Templeton Vol#: 4

EMC 704 Gail Ann Wachsmuth Vol#: 4

EMC 705 Susan F. Gellert Vol#: 4

EMC 706 Jeanne Perry Vol#: 4

EMC 707 Mary S. Lareau Vol#: 4

EMC 708 Patricia Hope Vol#: 4

EMC 709 Joseph A. Roussos Vol#: 4

EMC 710 Marion Leggo Vol#: 4

EMC 711 Elisabeth Wright Vol#: 4

EMC 712 Cheryl Nichols Vol#: 4

EMC 713 Lake Eakin Vol#: 4

EMC 714 Lori Veirs Vol#: 4

EMC 715 Edith Dalleska Vol#: 4

EMC 716 Joyce Cravener Vol#: 4

EMC 717 Robert Cravener Vol#: 4

EMC 718 Debra Potts Vol#: 4

EMC 719 Timothy Potts Vol#: 4

EMC 720 Diane Spreitzer Vol#: 4

EMC 721 Kathleen Bratby, MSN, RN Vol#: 4

EMC 722 Kathleen Bratby, MSN, RN Vol#: 4

EMC 723 Urdaneta Village Vol#: 4

EMC 724 Christina Phillips Vol#: 4

EMC 725 Monica Thomas Vol#: 4

EMC 726 Pauline N. Harding, MD Vol#: 4

EMC 727 Patricia Bergthold Vol#: 4

EMC 728 Sandra Dedinas Vol#: 4

EMC 729 Robin Fisher Vol#: 4

EMC 730 Hillary Shughart Vol#: 4

EMC 731 B. Ferrell Vol#: 4

EMC 732 Kendra G. Owen Vol#: 4

EMC 733 Susan Shackelton Vol#: 4

EMC 734 Sarah Roley, RN Vol#: 4

EMC 735 Patti McCausland Vol#: 4

EMC 736 Kevin McCausland Vol#: 4

EMC 737 Wendy Fleming Vol#: 4

EMC 738 Mark Fleming Vol#: 4

EMC 739 Carla Martin Vol#: 4

EMC 740 Kenneth Martin Vol#: 4

EMC 741 Jeremy Martin Vol#: 4

EMC 742 James Cravener Vol#: 4

EMC 743 Joseph J. Dunn Vol#: 4

EMC 744 George & Charlotte Bailey Vol#: 4

EMC 745 Pam Weldon Vol#: 4

EMC 746 Shula Edelkind Vol#: 4

EMC 747 Colleen Smether, CRNP Vol#: 4

EMC 748 Marilee Jones Vol#: 4

EMC 749 Barbara Keele Vol#: 4

EMC 750 Patricia T. Dunn Vol#: 4

EMC 751 Kathleen Bratby, MSN, RN Vol#: 4

EMC 752 Jane Hersey Vol#: 4

EMC 753 Markey Dokken Vol#: 4

EMC 754 Linda Mashuda Vol#: 4

EMC 755 Shula Edelkind Vol#: 4

EMC 756 Lynn Murphy Vol#: 4

EMC 757 Gloria Baldwin Vol#: 4

EMC 758 R.P. Townshend Vol#: 4

EMC 759 Wendy Clark Vol#: 4

EMC 760 Stacy Truett Vol#: 4

EMC 761 Kathleen Hampton Vol#: 4

EMC 762 American Academy of Child & Adolescent Vol#: 4

EMC 763 Julie Dixon Vol#: 4

EMC 764 Patti Saar Vol#: 4

EMC 765 Juliann Seebauer Vol#: 4

01P-0428 Generic Cefuroxime Axetil Products

SUP 1 ReedSmith Vol#: 2

01P-0445 ANDA suitability for Amiodarone hydrochloride tablets 100mg

WDL 1 Taro Pharmaceuticals U.S.A., Inc. Vol#: 1

01V-0215 Laser light show products

VRA 1 HFZ-340 to Oscar Photo Video Vol#: 1

01V-0326 Laser Light Show

VRA 1 HFZ-340 to Club Tango Vol#: 1

01V-0408

VRA 1 HFZ-340 to Shooters 21-Kansas City Vol#: 1

01V-0409

VRA 1 HFZ-340 to Sonny U. Lloyd Enterprises Vol#: 1

01V-0483

ACK 1 HFA-305 Vol#: 1

VAR 1 Rave Motion Pictures Vol#: 1