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 September 28, 2000

TABLE OF CONTENTS

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76N-052N OTC Nasal Decongestants*
95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient *
96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency *
99D-4809 Applications Covered by Section 505(b)(2) *
99P-1659 Withdrawal of ANDA for URSO or rename *
00D-0186 M4 Common Technical Document;InterNatl Confern on Harmonisat *
00D-1336 Pediatric Oncology Studies in Response to a Written Request *
00D-1392 Guidance for Industry on Botanical Drug Products *
00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals *
00D-1424 Analytical procedures and methods validation; drug substance *
00N-0930 Nominations for Working Groups: Pharmaceutical Science AC *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods *
76N-052N OTC Nasal Decongestants

Linked comments below also duplicate those for 81N-0022, also below

C 232 Consumer Healthcare Products Assn (CHPA) Vol#: 73

C 233 Consumer Healthcare Products Assn (CHPA) Vol#: 75

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

C 114 Consumer Healthcare Products Assn (CHPA) Vol#: 95

C 115 Consumer Healthcare Products Assn (CHPA) Vol#: 96

95P-0054 Refuse to Approve Any NDA for RU 486 used as abortifacient

C 299 Philip J Chenier Vol#: 5

C 300 Jon Blaeser Vol#: 5

C 301 Mark Fouth Vol#: 5

C 302 Marian Fech Vol#: 5

C 303 Deb Fouts Vol#: 5

C 304 Arlene Breitzman Vol#: 5

C 305 Jamie Hill Vol#: 5

C 306 Steve Steinmetz Vol#: 5

C 307 Mary C Thorson Vol#: 5

C 308 Robert J Breitzman Vol#: 5

C 309 Kurt J Apfelbeck Vol#: 5

C 310 Stephen E Berry Vol#: 5

C 311 Helen Steinmetz Vol#: 5

C 312 Thor A Thorson Vol#: 5

C 313 Mary Jo Walter Vol#: 5

C 314 Jessie Gretzinger Vol#: 5

C 315 McKenna & Cuneo LLP Vol#: 5

C 316 Form letter count 5 Vol#: 7

EMC 71 Jonathan Kopecky Vol#: 5

EMC 72 Gerald F Burr Vol#: 5

EMC 73 Shirley Schott Vol#: 5

EMC 74 Museumfac Vol#: 5

EMC 75 Sherry M Pfeifer Vol#: 5

EMC 76 Chris Kopecky Vol#: 5

EMC 77 Jill Clark Vol#: 5

EMC 78 Emily MacDonald Vol#: 5

EMC 79 Form letter count 12 Vol#: 6

96N-0393 MedWatch:FDA's Medical Prod Reporting Program Forms; Agency

C 26 Amgen Inc. Vol#: 1

99D-4809 Applications Covered by Section 505(b)(2)

C 10 McKenna & Cuneo, L.L.P. Vol#: 1
 

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

C 15203 Michael Smith Vol#: 454

C 15204 Michael Nortz Vol#: 454

C 15205 Ann Z. Bell Vol#: 454

C 15206 Judy Ferger Vol#: 454

C 15207 Bette L. Moffett Vol#: 454

C 15208 Catherine E. Paff Vol#: 454

C 15209 Joseph A. Ojeda Vol#: 454

C 15210 Frances M. Kelly Vol#: 454

EMC 3125 Deborah Temple Vol#: 454

99P-1659 Withdrawal of ANDA for URSO or rename

LET 2 Novartis Pharmaceutical Corporation Vol#: 1

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

C 6 Pharmacia Corp. Vol#: 1

00D-1336 Pediatric Oncology Studies in Response to a Written Request

C 4 Bristol-Myers Squibb Pharm Res Institute Vol#: 1

00D-1392 Guidance for Industry on Botanical Drug Products

C 1 Missouri Botanical Garden Vol#: 1

EXT 1 Sidley & Austin Vol#: 1

00D-1407 Safety Pharmacology Studies for Human Pharmaceuticals

C 5 AstraZeneca Pharmaceuticals LP Vol#: 1

00D-1424 Analytical procedures and methods validation; drug substance

C 1 Greg Bobrowicz & Associates Vol#: 1

00N-0930 Nominations for Working Groups: Pharmaceutical Science AC

C 4 SmiyhKline Beecham Pharms. Vol#: 1

00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal

C 35 Clover L Lowing Vol#: 11

C 36 Ginger Messina Vol#: 11

EMC 103 Lauren Blaschke Vol#: 11

EMC 104 Peter Kowalke Vol#: 11

EMC 105 Bonita R Kruse Vol#: 11

EMC 106 Martha Wickelhaus Vol#: 11

EMC 107 Heather Alexander Vol#: 11

EMC 108 Timothy Gallagher Vol#: 11

EMC 109 Marian Buckner Vol#: 11

EMC 110 Kandace G Thorns Vol#: 11
 
 

00N-1364 Prescription Drug User Fee Act (PDUFA) Public Meeting

C 2 CFL, Cure for Lymphoma Foundation Vol#: 1

TS 18 CMR International Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

C 6295 Mark A. Camella Vol#: 269

C 6296 Cindy Schafer & Bruce Haskitt Vol#: 269

C 6297 Mr & Mrs Virgis Franks Vol#: 269

C 6298 Harry Bargian Vol#: 269

C 6299 Rosamund Downing Vol#: 269

C 6300 Mark J. Sicherman, MD Vol#: 269

C 6301 Judith A. Sims Vol#: 269

C 6302 S. A. Andres Vol#: 269

C 6303 Aleda S. Jackson Vol#: 269

C 6304 Chandra Alexandre Vol#: 269

C 6305 Cor Knijinenburg Vol#: 269

C 6306 Marie L. Stewart Vol#: 269

C 6307 Virginia Kerns Vol#: 269

C 6308 Lorita Whitehead Vol#: 269

C 6309 Miranda Alexander Vol#: 269

C 6310 Laurynas R. Misevicius Vol#: 269

C 6311 Mr & Mrs Gordon Branche Vol#: 269

C 6312 Malcome B. Hale Vol#: 269

C 6313 Keith Guenther Vol#: 269

C 6314 Jerry L. Oswalt Vol#: 269

C 6315 Angela Angus-Koppes Vol#: 269

C 6316 Martha Speirs Vol#: 269

C 6317 Marla Cheppa Vol#: 269

C 6318 Thelma E. Wiegel Vol#: 269

C 6319 Kay Glenn Vol#: 269

C 6320 Cynthia Bottoms Vol#: 269

C 6321 D. Vaughter Vol#: 269

C 6322 Robert M. Blumer Vol#: 269

C 6323 Maryanne Galbraith Vol#: 269

C 6324 Andy Guiterrez Vol#: 269

C 6325 Shirley A. Davis Vol#: 269

C 6326 Guy Vasilovich Vol#: 269

C 6327 Mr & Mrs Wayne M. Compton Vol#: 269

C 6328 Marilyn Von Brocklin Vol#: 269

C 6329 Marie Tricarico Vol#: 269

C 6330 James E. Larson Vol#: 269

C 6331 M. Gehlhar Vol#: 269

C 6332 Barbara Patrick Vol#: 269

C 6333 Martha Vanderhyde Vol#: 269

C 6334 Janet Moffett Vol#: 269

C 6335 Doris Klapper Vol#: 269

C 6336 Sandra Fox Vol#: 269

C 6337 Michelle Knijinenburg Vol#: 269

C 6338 Matt Meyers Vol#: 269

EMC 2767 Alicia Lomne Vol#: 269

EMC 2768 Liza Knowles Vol#: 269

EMC 2769 Lesley McMahon Vol#: 269

EMC 2770 Deana McCauley Vol#: 269

EMC 2771 Esther Wagner Vol#: 269

EMC 2772 Kathleen Allen Vol#: 269

EMC 2773 Roberta Hill Vol#: 269

EMC 2774 Christine Gonzalez Vol#: 269

EMC 2775 Nicole Foland Vol#: 269

EMC 2776 Marlena Machol Vol#: 269

EMC 2777 Irene Goodell Vol#: 269

EMC 2778 B. G. & Lloyd Goodwon Vol#: 269

EMC 2779 Bennie Rovelo Vol#: 269

EMC 2780 Wendy Seaberg Vol#: 269

EMC 2781 William DeVore Vol#: 269

EMC 2782 Carol Honeycutt Vol#: 269

EMC 2783 Neva Glenn Vol#: 269

EMC 2784 Lori Cockshutt Vol#: 269

EMC 2785 Mary Wildfire Vol#: 269

EMC 2786 Stacy Horrigan Vol#: 269

EMC 2787 Noel Petrie Vol#: 269

EMC 2788 Kathleen Kemp Vol#: 269

EMC 2789 Marian Porter Vol#: 269

EMC 2790 Thomas Gonick Vol#: 269

EMC 2791 Angeleen DelRosso Vol#: 269

EMC 2792 Gail Beeson Vol#: 269

EMC 2793 Sharon Sutherland Vol#: 269

EMC 2794 Alicia Jaffe Vol#: 269

EMC 2795 Victoria Long Vol#: 269

EMC 2796 Patricia Goodkind Vol#: 269

EMC 2797 Steve Suppan Vol#: 269

EMC 2798 Lauren Gwin Vol#: 269

EMC 2799 Edna Egli Vol#: 269

EMC 2800 Hea McGovern Vol#: 269

EMC 2801 Devi Barnard Vol#: 269

EMC 2802 Stephanie Phippen Vol#: 269

EMC 2803 Spencer Phippen Vol#: 269

EMC 2804 Deborah Temple Vol#: 269

EMC 2805 Randi Seider Vol#: 269

EMC 2806 Marie Mattera Vol#: 269

EMC 2807 Randy Poplock Vol#: 269

EMC 2808 T. McCormick Vol#: 269

EMC 2809 Hillary Caws-Elwitt Vol#: 269

EMC 2810 Shannon Belding Vol#: 269

EMC 2811 Sue Smith-Heavenrich Vol#: 269

EMC 2812 Christopher Schultz Vol#: 269

EMC 2813 Lillian McDonell Vol#: 269

EMC 2814 Ron Barnhardt Vol#: 269

EMC 2815 Leslie Christensen Vol#: 269

EMC 2816 Kristy Stoever Vol#: 269

EMC 2817 Bill Plummer Vol#: 269

EMC 2818 Jesse Schomberg Vol#: 269

EMC 2819 Alma Dorsey Vol#: 269

EMC 2820 Moriah Smith Vol#: 269

EMC 2821 Barry Wraga Vol#: 269

EMC 2822 Janice Caputo Vol#: 269

EMC 2823 Lulu Walker Vol#: 269

EMC 2824 Ashley Netherwood Vol#: 269

EMC 2825 Liz Clarke Vol#: 269

EMC 2826 Mary S. Baler Vol#: 269

EMC 2827 Bill Rogers Vol#: 269

EMC 2828 Audrey Godshall Vol#: 269

EMC 2829 Betty Wilson Vol#: 269

EMC 2830 Peter Trivelas Vol#: 269

EMC 2831 Carolyn Davids Vol#: 269

EMC 2832 Meredyth Dunsmore Vol#: 269

EMC 2833 Kathy Kochis Vol#: 269

EMC 2834 Nancy Gibson Vol#: 269

EMC 2835 Debbie McDonald Vol#: 269

EMC 2836 Phil Bedell Vol#: 269

EMC 2837 Heather Ryan Vol#: 269

EMC 2838 Jackie Patru Vol#: 269

EMC 2839 Lynne Horst Vol#: 269

EMC 2840 Joseph Quickle Vol#: 269

EMC 2841 Cindy Macolini Vol#: 269

EMC 2842 Paula Puhak Vol#: 269

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

C 1 Glaxo Wellcome, Inc. Vol#: 1