DOCKETS ENTERED on 07/01/99

Food and Drug Administration

DOCKETS ENTERED on July 1, 1999

(Hyper links are at the end of the Docket title - click on * )

92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
97N-0165 Pediatric Patients certain new drugs/biological Products *
97P-0478 Safety of UVA tanning unit labeling and use*
98D-1171 Platelet Testing & Evaluation of Platelet Substitute Product *
98D-1218 Pilot program for gamma irradiated blood & blood components *
98N-1038 Irradiation in the production, processing, &handling of food *
98N-1170 Sunlamp Products Performance Standard*
98N-1265 Distribution of Compounded Drug Products*
98P-0203 Eliminate Forced Molting of Laying Birds*
98P-0504 Raw Molluscan Shellfish of Undetectable Levels*
98P-1194 Withdrawal NADA Approval for Posilac - rBGH*
98P-1228 Amend GRAS Status for Nisin *
99D-0557 Use of Nonhuman Primate Xenografts in Humans*
99N-0926 Regulations under the Federal Imporot Milk Act;Agency Inform *
99P-0033 Combat the spread of transmissible spongiform encephalopathy *
99P-0301 Amend the Peanut Spread Regulations*
99P-1271 Stay of Action Regarding Approval of Cisplatin Injection *
99P-1340 Declared Eternity eau de Parfum Misbranded*
99P-2146 Designate Fosamax (alendronate sodium) as an alternate refer *
99P-2147 Ban the use of silicone gel-filled breast implant *
99P-2148 Label or Labeling of food ingredients and regulation *
99V-2142 Laser light show *

92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5626 Nancy L Weber Vol#: 133

C 5627 Kathleen Fogarty Vol#: 133

C 5628 Gaby S Robey Vol#: 133

C 5629 Ms Helen Pitton Vol#: 133

C 5630 Ms Lyndis Durwin Vol#: 133

C 5631 Mary L Rutt Vol#: 133

C 5632 Mr & Mrs H K Alder Vol#: 133

C 5633 Jenifer Groves Vol#: 133

C 5634 Dr Lorilee Schoenbeck Vol#: 133

97N-0165 Pediatric Patients certain new drugs/biological Products

OB 1 BIO, Biotechnology Industry Organization Vol#: 6

97P-0478 Safety of UVA tanning unit labeling and use

C 2 Custom Group Marketing Corp Vol#: 1

98D-1146 Microbial effects of antimicrobial new animal drugs/human sa

C 56 Mayfield Enterprises, Inc Vol#: 2

98D-1171 Platelet Testing & Evaluation of Platelet Substitute Product

C 1 McMaster University Vol#: 1

98D-1218 Pilot program for gamma irradiated blood & blood components

C 4 University of Cambridge Nat Blood Servic Vol#: 1

98H-1082 Civil Money Penalties;Ocean Springs Biloxi Koa Inc,d/b/a Oce

LET 2 Office of Tobacco Programs (HF-11) Vol#: 1

98N-1038 Irradiation in the production, processing, &handling of food

C 3058 American Preventive Medical Assn. Vol#: 85

C 3059 Jill McGrath & Richard Gelb Vol#: 85

C 3060 Jim & Diane Erwin Vol#: 85

C 3061 Christine Louise Weiss Vol#: 85

C 3062 Daniel B. Weiss Vol#: 85

C 3063 Caryn Wertheimer Vol#: 85

C 3064 Lisa Hezel Vol#: 85

C 3065 Jean Keller Vol#: 85

C 3066 Norman Cohen Vol#: 85

C 3067 Laura Garon Vol#: 85

C 3068 Dannell G. Wells Vol#: 85

C 3069 Jenifer Dawson Vol#: 85

C 3070 Nancy A. & Jack Stiefel Vol#: 85

C 3071 Virginia Hughes Vol#: 85

C 3072 Robert R. Cheeks Vol#: 85

C 3073 Angelica Williams Vol#: 85

C 3074 R. Morantz Vol#: 85

C 3075 Irena Franchi & Ilene Arce Vol#: 85

C 3076 Suzanne Olson Vol#: 85

C 3077 James Leong Vol#: 85

C 3078 Lucinda Labes Vol#: 85

C 3079 Etta Linton Vol#: 85

C 3080 Donald H. McNeill Vol#: 85

C 3081 Monte Rolls Vol#: 85

C 3082 Pensatrix Vol#: 85

98N-1170 Sunlamp Products Performance Standard

C 13 Interlectric Corp. Vol#: 1

98N-1265 Distribution of Compounded Drug Products

C 3313 Jean A. Johnson Vol#: 122

C 3314 O'Brien Pharmacy Vol#: 122

C 3315 O'Brien Pharmacy Vol#: 122

C 3316 O'Brien Pharmacy Vol#: 122

C 3317 Jewel E. Offermann Vol#: 122

C 3318 Joi Fon Johnson Vol#: 122

C 3319 Constance V. Hanson Vol#: 122

C 3320 Nancy Palmer Vol#: 122

C 3321 Karen Weinberg Vol#: 122

C 3322 Cheryl Ann Procunier Vol#: 122

C 3323 Joan B. Silberman Vol#: 122

C 3324 S. Lent Vol#: 122

C 3325 Martha C. West Vol#: 122

C 3326 O'Brien Pharmacy Vol#: 122

98P-0203 Eliminate Forced Molting of Laying Birds

C 1661 Sarabeth S Nelson Vol#: 41

C 1662 Christine Miller Vol#: 41

C 1663 Mary Phyllis Horn Vol#: 41

C 1664 Bob Sullivan Vol#: 41

C 1665 D Kelly Forbes Vol#: 41

C 1666 Dr & Mrs Mark Mathis Vol#: 41

C 1667 Mr & Mrs George Wood Vol#: 41

C 1668 Greg Karl Vol#: 41

C 1669 Illegible Vol#: 41

C 1670 Maxine Jaffee Vol#: 41

C 1671 Donna Bradley Vol#: 41

C 1672 R Capozzelli Vol#: 41

C 1673 Jessica Grodio Vol#: 41

C 1674 Ellen Milbank Vol#: 41

C 1675 Ms Sharon Cox Vol#: 41

C 1676 Elaine Ritchey Vol#: 41

C 1677 Debbie Cravatta Vol#: 41

C 1678 Belinda Bourecksky Vol#: 41

C 1679 Migmin Demma Vol#: 41

C 1680 Mrs P M Nixon Vol#: 43

C 1681 Carla J Cicchi Vol#: 43

C 1682 Mary Frock Vol#: 43

C 1683 Christa Tinari Vol#: 43

C 1684 Liana Stanton Vol#: 43

C 1685 PETA Vol#: 43

98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 262 Annie L. Keil Vol#: 18

C 263 Karolyn Dleal Vol#: 18

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 159 Kathleen Fogarty Vol#: 3

C 160 Jenifer Groves Vol#: 3

C 161 Mr & Mrs J. Stgermain Vol#: 3

98P-1228 Amend GRAS Status for Nisin

LET 1 HFS-200 to Stephanie Heather Brown Vol#: 1

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 115 Marc L Gutchell Vol#: 4

C 116 Jamie L Cohen Vol#: 4

C 117 Karen E Purves Vol#: 4

C 118 Rebecca Delrae Vol#: 4

C 119 Alix Fano Vol#: 4

C 120 Ellen Henry Vol#: 4

C 121 William McMullin Vol#: 7

C 122 Joni Crippen Vol#: 7

C 123 Thomas H Adcock Vol#: 7

C 124 Jan Creamer Vol#: 7

C 125 Michael Dachnick Vol#: 7

C 126 Martine Sankari Vol#: 7

C 127 Marianne R Merritt Vol#: 7

C 128 Jamie Schaefer Vol#: 7

C 129 Mary Margaret Cunniff Vol#: 4

99H-1300 Civil Money Penalties;R O Lewis Inc & Ron O Lewis,d/b/a Jahn

LET 2 Office of Tobacco Programs Vol#: 1

99H-1913 Civil Money Penalty;Arelni, A Ltd Liability Co,dba Oasis Gif