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DOCKETS ENTERED on September 19, 2000

TABLE OF CONTENTS

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75N-183F Topical Antimicrobial Drug Products For OTC Human Use *
78N-0301 OTC External Analgesic Drug Products *
96D-0009 Impurities in new drug products guideline *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
97P-0078 Recognized the Term "Soymilk" as the Established Common of U *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99N-1979 Apple Cider Food Safety Control *
99P-5106 Identify Sources of Natural Flavorings *
99V-5521 Laser Light Show, SpectraScan LitePipe LP2-X Mobolazer *
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal *
00N-1460 Salmonella Enteritidis Research Public Meeting *
00P-0425 To amend 21 CFR 107 Subpart B,labeling of infant formulas *
00P-0685 Revise of Yogurt Standards *
00P-1265 Performance standard for electrode lead wires & patient cabl *

75N-183F Topical Antimicrobial Drug Products For OTC Human Use

RPT 1 Rickitt Benckiser Pharmaceuticals Inc Vol#: 8

78N-0301 OTC External Analgesic Drug Products

LET 87 HFD-560 to Thompson Medical Vol#: 99

91G-0253 Affirmation of GRAS Status for Caprenin

ANS 1 HFS-215 Vol#: 1

WDL 1 Procter & Gamble Vol#: 1

96D-0009 Impurities in new drug products guideline

C 4 Merck Research Laboratories Vol#: 1

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

ANS 1 HFW-14 to Hon. John D. Dingell Vol#: 201

ANS 2 HFW-14 to Hon. Michael Bilirakis Vol#: 201

ANS 3 HFW-14 to Hon. Steny H. Hoyer Vol#: 201

ANS 4 HFW-14 to Hon. Richard Burr Vol#: 201

ANS 5 HFW-14 to Hon. Patrick J. Kennedy Vol#: 201

97P-0078 Recognized the Term "Soymilk" as the Established Common of U

C 138 Western Quality Food Products, LC Vol#: 2

C 139 Dean Foods Company Vol#: 2

C 140 Suzanne House Vol#: 2

97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 5617 Country Life Vol#: 45

LET 5618 Heritage Consumer Products Vol#: 45

LET 5619 Country Life Vol#: 45

LET 5620 Country Life Vol#: 45

LET 5621 Perrigo Company of South Carolina Vol#: 45

LET 5622 Emord & Associates, P.C. Vol#: 45

LET 5623 Country Life Vol#: 45

LET 5624 E'Ola International Vol#: 45

LET 5625 E'Ola International Vol#: 45

LET 5626 Vitamer, Div. of Anabolic Laboratories Vol#: 45

LET 5627 Vitamer, Div. of Anabolic Laboratories Vol#: 45

LET 5628 Vitamer, Div. of Anabolic Laboratories Vol#:

LET 5629 Vitamer, Div. of Anabolic Laboratories Vol#: 45

LET 5630 Roex Inc. Vol#: 45

LET 5631 Roex Inc. Vol#: 45

LET 5632 Roex Inc. Vol#: 45

LET 5633 Roex Inc. Vol#: 45

LET 5634 Roex Inc. Vol#: 45

LET 5635 Roex Inc. Vol#:

LET 5636 Roex Inc. Vol#: 45

LET 5637 Roex Inc. Vol#: 45

LET 5638 Roex Inc. Vol#: 45

LET 5639 Roex Inc. Vol#: 45

LET 5640 Roex Inc. Vol#: 45

LET 5641 Roex Inc. Vol#: 45

LET 5642 Roex Inc. Vol#: 45

LET 5643 NOW Vol#: 45

LET 5644 Country Life Vol#: 45

LET 5645 Aquasearch Inc. Vol#:

LET 5646 Perrigo Company of South Carolina Vol#: 45

LET 5647 Perrigo Company of South Carolina Vol#:

LET 5648 Perrigo Company of South Carolina Vol#: 45

LET 5649 Perrigo Company of South Carolina Vol#: 45

LET 5650 Standard Process Vol#: 45

LET 5651 Standard Process Vol#: 45

LET 5652 Standard Process Vol#: 45

LET 5653 Standard Process Vol#: 45

LET 5654 Standard Process Vol#: 45

LET 5655 Standard Process Vol#: 45

LET 5656 Longevity Nutaceutical Labs Vol#: 45

LET 5657 Desert Lake Technologies, LLC Vol#: 45

LET 5658 NBTY, Inc. Vol#: 45

LET 5659 NBTY, Inc. Vol#: 45

LET 5660 NBTY, Inc. Vol#: 45

LET 5661 NBTY, Inc. Vol#: 45

LET 5662 NBTY, Inc. Vol#: 45

LET 5663 NBTY, Inc. Vol#: 45

LET 5664 NBTY, Inc. Vol#: 45

LET 5665 NBTY, Inc. Vol#: 45

LET 5666 NBTY, Inc. Vol#: 45
 

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

C 26 Animal Health Institute Vol#: 16
 
 

98N-0044 Effect of dietary supplement on structure/function of body

LET 6 Buc & Beardsley Vol#: 882
 
 

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding

C 172 Cynthia Turner Vol#: 21

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

C 2323 Debra E Marler & 6 signatures Vol#: 67

C 2324 Delores & Frank Leake Vol#: 67

C 2325 Kristin M Johnson Vol#: 67

EMC 1 Gina Downey Vol#: 67

EMC 2 Jona French Vol#: 67

99N-1979 Apple Cider Food Safety Control

EMC 1 Kate Broughton Vol#: 1
 
 

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

C 14833 Lynne Theis Vol#: 447

C 14834 Elaine Doremus Vol#: 447

C 14835 Julia Balter Vol#: 447

C 14836 Mr & Mrs J. Ness Vol#: 447

C 14837 Karen Lee Gillis Vol#: 447

C 14838 Moise E. Berger Vol#: 447

C 14839 Ingeborg Kuhn Vol#: 447

C 14840 Dara Levine Vol#: 447

C 14841 John W. Julson Vol#: 447

C 14842 Penny Harding Vol#: 447

C 14843 Dinah Hathaway Vol#: 447

C 14844 Richard Caplan Vol#: 447

C 14845 Jerri Brandt Vol#: 447

C 14846 Dorothy Dwyer Vol#: 447

C 14847 Leif Wefferling Vol#: 447

C 14848 Todd Gilbert Vol#: 447

C 14849 Martine Sankuri Vol#: 447

C 14850 Nadia Hartman Vol#: 447

C 14851 John M. Wade Vol#: 447

C 14852 Peg Marain Vol#: 447

C 14853 Ms. Lauren Ryan Stewart Vol#: 447

C 14854 Charlene Martwick Vol#: 447

C 14855 Georgia L. Fogg Vol#: 447

C 14856 William F. McVay Vol#: 447

C 14857 Anna E. Herb Vol#: 447

C 14858 Juanita P. Conley Vol#: 447

C 14859 Mary E. McRae Vol#: 447

C 14860 Mollie M. McBride Vol#: 447

C 14861 Alfred L. Dyott Vol#: 447

C 14862 Shirley M. Messer Vol#: 447

C 14863 Justin A. Trowbridge Vol#: 447

C 14864 Mary Deanne Jones Vol#: 447

C 14865 William Lindermau & Veroncue DeJaeger Vol#: 447

C 14866 Mannine Frankstone Vol#: 447

C 14867 Bonnie J. Bake Vol#: 447

C 14868 R. A. Hollingsworth Vol#: 447

C 14869 Jean & Bob Smecher Vol#: 447

C 14870 Alice Stadig Vol#: 447

C 14871 Donald E. Daggett Vol#: 447

C 14872 Justina Gillo Vol#: 447

C 14873 Audrey L. Tillung Vol#: 447

EMC 3071 Western Governor's Association Vol#: 450

EMC 3072 Indya Gordon Vol#: 450

EMC 3073 Felicia McMahon Vol#: 450

99P-5106 Identify Sources of Natural Flavorings

C 6 Natalie M. Diehl Vol#: 1

99V-5521 Laser Light Show, SpectraScan LitePipe LP2-X Mobolazer

ACK 2 HFA-305 Vol#: 1

VAR 2 Pyro Magic Inc., DBA Laser Pyro Shows Vol#: 1

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

EC 59 N/A Vol#: 11

EC 60 CORE Vol#: 11

EC 61 Risorgimento Project Vol#: 11
 
 

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

BKG 1 Background Material Vol#: 1

LST 1 FDA & Patient Advocacy Groups Vol#: 1

TS 1 HFD-001 Vol#: 1

TS 2 HFD-10 Vol#: 1

TS 3 CBER Vol#: 1

TS 4 Tufts Center for the Study of Drug Dev Vol#: 1

TS 5 BlueCross BlueShield Assn Vol#: 1

TS 6 Tufts Center for the Study of Drug Dev Vol#: 1

TS 7 Generic Pharmaceutical Assn Vol#: 1

TS 8 National Women's Health Network Vol#: 1

TS 9 National Organization of Rare Disoders Vol#: 1

TS 10 National Health Council Vol#: 1

TS 11 Kidney Cancer Association Vol#: 1

TS 12 Patients and Consumers Coalition Vol#: 1

TS 13 American Pharmaceutical Assn Vol#: 1

TS 14 National Consumers League Vol#: 1

TS 15 Public Citizen's Health Research Group Vol#: 1

TS 16 Center for Medical Consumers Vol#: 1

TS 17 National Assn of Pharmaceutical Manuf Vol#: 1

00N-1460 Salmonella Enteritidis Research Public Meeting

EMC 1 Jean Guard Petter Vol#: 1

00P-0425 To amend 21 CFR 107 Subpart B,labeling of infant formulas

LET 1 CFSAN/ONPLDS Vol#: 1

00P-0685 Revise of Yogurt Standards

LET 1 CFSAN/ONPLDS Vol#: 1

00P-1265 Performance standard for electrode lead wires & patient cabl

SUP 1 Biosense Webster Inc Vol#: 1