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] 

DOCKETS ENTERED on September 1, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE] [FDA HOME PAGE]

 
78N-036L OTC Laxative *
87F-0179 Sucrose polyester as replacement for fats & oil in food *
94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST *
96P-0215 Withdrawal Norplant's approval for sale in the United States *
96P-0328 Modify 640.3(d) after 'Therapeutic Bleedings' *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98P-0418 Olestra & other Partially or Totally Nondigestible Fats *
98P-1121 Grated Parmesan Cheese Deviating from Identity standard *
99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA *
99D-2248 Efficacy of Anthelmintics for Bovines,Ovines and Caprines *
99N-0193 Supplements and Other Changes to an Approved Application *
99N-1220 Draft Civil Money Penalty Reduction Policy for Small Entitie *
99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat *
99P-1416 Methylphenidate Hydrochloride Oral Solution (5mg/mL&10mg/5Ml *
99P-2408 Prohibit Use of Potassium Bromate as a Food Ingredient *
99V-3020 Laser Light Show *
99V-3021 *
99V-3080 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, *
78N-036L OTC Laxative

C 199 MaryAnn Pace Chase Vol#: 107

87F-0179 Sucrose polyester as replacement for fats & oil in food

OB 129 William F. Goodling (CI) Vol#: 34

OB 130 Frito-Lay, Inc. Vol#: 34

94D-0025 Interim GDL/Labeling Milk & Milk Products from Cows w/rbST

C 8556 Norma R. De Yagcier Vol#: 115

96P-0215 Withdrawal Norplant's approval for sale in the United States

C 208 Susan Jorgensen Vol#: 5

96P-0328 Modify 640.3(d) after 'Therapeutic Bleedings'

C 62 Donna M. Borngraher & Joan Marbery Vol#: 1

C 63 Paula Ryan-Richard Vol#: 1

C 64 Richard H. Wood, Jr Vol#: 1

C 65 Peter M. Rinaldo Vol#: 1

C 66 Mervyn F. Frandy Vol#: 1

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE LINKED COMMENTS DUPLICATE THOSE FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 117 Charles Mizrahi Vol#: 5

C 118 Daniel Mishaan Vol#: 5

C 119 Ms. Diana Petrella Vol#: 5

C 120 Janet Lyons Vol#: 5

C 121 Madeline Dalton Vol#: 5

C 122 Nancy Zierenberg Vol#: 5

C 123 Kathleen McQuilling Vol#: 5

C 124 Pat Grant Vol#: 5

C 125 Madonna Niles Vol#: 5

C 126 Anne Brown Vol#: 5

C 127 April J. Boyle Vol#: 5

C 128 Nicolas Atwood Vol#: 5

C 129 Hal & Pauline Baerg Vol#: 5

C 130 Ellen Henry Vol#: 5

97N-0435 New animal drug regulation/substantial evidence

REF 1 HF-26 Vol#: 1

97P-0197 Require that warning labels about risks of salmonella enteri

C 118 Charles Mizrahi Vol#: 4

C 119 Daniel Mishaan Vol#: 4

C 120 Ms. Diana Petrella Vol#: 4

C 121 Janet Lyons Vol#: 4

C 122 Madeline Dalton Vol#: 4

C 123 Nancy Zierenberg Vol#: 4

C 124 Kathleen McQuilling Vol#: 4

C 125 Pat Grant Vol#: 4

C 126 Madonna Niles Vol#: 4

C 127 Anne Brown Vol#: 4

C 128 April J. Boyle Vol#: 4

C 129 Nicolas Atwood Vol#: 4

C 130 Hal & Pauline Baerg Vol#: 4

C 131 Ellen Henry Vol#: 4

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

LET 3771 Standard Process Inc c Vol#: 24

LET 3772 Natrol Inc Vol#: 24

LET 3773 Herb Pharm Vol#: 24

LET 3774 Nature's Herbs Vol#: 24

LET 3775 NBTY Inc Vol#: 24

LET 3776 Standard Process Inc Vol#: 24

LET 3777 Traditional Medicinals Inc Vol#: 24

LET 3778 Traditional Medicinals Inc Vol#: 24

LET 3779 Traditional Medicinals Inc Vol#: 24

LET 3780 Source Naturals Vol#: 24

LET 3781 Source Naturals Vol#: 24

LET 3782 Natrol Inc Vol#: 24

LET 3783 Source Naturals Vol#: 24

LET 3784 Kaire Nutraceuticals Inc Vol#: 24

LET 3785 Kaire Nutraceuticals Inc Vol#: 24

LET 3786 Kaire Nutraceuticals Inc Vol#: 24

LET 3787 Plainview LLC Vol#: 24

LET 3788 Plainview LLC Vol#: 24

LET 3789 Natrol Inc Vol#: 24

LET 3790 Leiner Health Products Vol#: 24

LET 3791 Leiner Health Products Vol#: 24

LET 3792 Leiner Health Products Vol#: 24

LET 3793 Herbal Science Inc Vol#: 24

LET 3794 Herbal Science Inc Vol#: 24

LET 3795 Herbal Science Inc Vol#: 24

LET 3796 Herbal Science Inc Vol#: 24

LET 3797 Herbal Science Inc Vol#: 24

LET 3798 Herbal Science Inc Vol#: 24

LET 3799 Herbal Science Inc Vol#: 24

LET 3800 Herbal Science Inc Vol#: 24

LET 3801 Kaire Nutraceuticals Inc Vol#: 24

LET 3802 Vitalife Inc Vol#: 24

LET 3803 Natural Balance Inc Vol#: 24

LET 3804 Natural Balance Inc Vol#: 24

LET 3805 Enzamin USA Inc Vol#: 24

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 117 Charles Mizrahi Vol#: 8

C 118 Daniel Mishaan Vol#: 8

C 119 Ms. Diana Petrella Vol#: 8

C 120 Janet Lyons Vol#: 8

C 121 Madeline Dalton Vol#: 8

C 122 Nancy Zierenberg Vol#: 8

C 123 Kathleen McQuilling Vol#: 8

C 124 Pat Grant Vol#: 8

C 125 Madonna Niles Vol#: 8

C 126 Anne Brown Vol#: 8

C 127 April J. Boyle Vol#: 8

C 128 Nicolas Atwood Vol#: 8

C 129 Hal & Pauline Baerg Vol#: 8

C 130 Ellen Henry Vol#: 8

98P-0418 Olestra & other Partially or Totally Nondigestible Fats

C 1 William F. Goodling (CI) Vol#: 1

98P-1121 Grated Parmesan Cheese Deviating from Identity standard

LET 1 Kraft Foods, Inc. Vol#: 1

LET 2 Kraft Foods, Inc. Vol#: 1

99D-0529 Draft Guidance for Ind - Changes to an Approved NDA or ANDA

C 28 Baxter Healthcare Corporation Vol#: 2

C 29 Abbott Laboratories Vol#: 2

99D-2248 Efficacy of Anthelmintics for Bovines,Ovines and Caprines

C 1 Animal Health Institute Vol#: 1

99N-0193 Supplements and Other Changes to an Approved Application

C 4 CEFIC Active Pharm Ingredients Comte Vol#: 1

99N-1220 Draft Civil Money Penalty Reduction Policy for Small Entitie

C 1 Health Industry Manufacturers Assn Vol#: 1

99N-1737 Clinical Trials for Invest Devices Intended to Treat Threat

C 1 Steven Rohr Vol#: 1

99P-1416 Methylphenidate Hydrochloride Oral Solution (5mg/mL&10mg/5Ml

THIS LINKED COMMENT DUPLICATE THOSE FOR 99P-1417 AND 99P-1418, ALSO BELOW

AMD 1 Lachman Consultant Services, Inc Vol#: 1

99P-1417 Methylphenidate Hydrochloride Chewable tablets 5mg & 10mg

AMD 1 Lachman Consultant Service, Inc. Vol#: 1

99P-1418 Methylphenidate Hydrochloride Chewable Tablets, 2.5mg

AMD 1 Lachman Consultant Services, Inc Vol#: 1

99P-2408 Prohibit Use of Potassium Bromate as a Food Ingredient

SUP 1 Center for Science in the Public Interes Vol#: 1

99V-3020 Laser Light Show

ACK 1 HFA-305 Vol#: 1

99V-3021

ACK 1 HFA-305 Vol#: 1

99V-3080 Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-1.0

ACK 1 HFA-305 Vol#: 1

VAR 1 Doug Vierling Vol#: 1