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 October 19, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
93V-0377 Laser Light Show *
97P-0034 Establish std limits for lead in calcium supplements & Antac *
97P-0233 Maintain current system establishing lead limits food & drug *
97P-0341 Regulate cigars, little cigars, as nicotine delivery systems *
97V-0081 Laser Light Show *
98N-0359 Program priorities/Center for Food Safety & Applied Nutritin *
98N-0581 Requirements for Testing Human Blood Donors *
98N-1038 Irradiation in the production, processing,handling of food
98P-0145 Requirements for demonstrating In Vivo Bioequivalence *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-0203 Eliminate Forced Molting of Laying Birds *
98P-0624 Permit approval of ANDAs filed for ticlopidine hydrochloride *
98P-0694 Determine Exclusivity date for Diltiazem Hydrichloride *
98P-0821 Hydromorphone Hydrochloride Injection *
99D-2636 Guidance for Industry on Levothyroxine Sodium *
99N-1307 Preliminary Regulatory Impact Analysis and Initial Regulatoy *
99N-2151 New Animal Drug Applications; Sheep as a Minor Species *
99P-0792 Approval of Dosage Strengths*
99P-1340 Declared Eternity eau de Parfum Misbranded *
99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone *
99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease *
99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia *
99V-0125 Laser Light Show Laserium CSMX250*
99V-0190 Variance Laser Light Show LSD110XL MRAK10 & MRAK250 *
99V-0294 Laser light show *
99V-0556 Medical Laser on display *
99V-1088 Laser Light Show, LaserXpress*
99V-4463 Laser Light Show *
92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 6109 Amy Sabala Vol#: 152

C 6110 Mr & Mrs P Steinberg Vol#: 152

C 6111 Cheryl Aiken Vol#: 152

C 6112 Joan Gray Vol#: 152

C 6113 Deborah Ensign Vol#: 152

C 6114 Howard Spivak Vol#: 152

C 6115 Mr & Mrs Low Vol#: 152

C 6116 Elizabeth Russet Vol#: 152

C 6117 Albert Kaufman Vol#: 152

C 6118 Margaret C Pierce Vol#: 152

C 6119 E Ann Hosmer MD Vol#: 152

C 6120 Amanda Wilson Vol#: 152

C 6121 Wm H Evans Vol#: 152

C 6122 Jackie Stevens Vol#: 152

C 6123 Dan Golembeski Vol#: 152

C 6124 Donald & Ellen Bliss Vol#: 152

C 6125 Nancy A Mulle Vol#: 152

C 6126 Susan Stephenson Vol#: 152

C 6127 Mary Devereaux Vol#: 152

C 6128 Sarah Barlotta Vol#: 152

C 6129 Jane Van Dusen Vol#: 152

C 6130 Doris Andrews Vol#: 152

C 6131 Jessica Murdaugh PhD Vol#: 156

C 6132 George Fox Vol#: 156

C 6133 Adria Skikos Vol#: 156

C 6134 Debbie Skikos Vol#: 156

C 6135 Mark H V Der Gaag Vol#: 156

C 6136 Miriam Dailey Vol#: 156

C 6137 Susan Shapiro Vol#: 156

C 6138 Gene Salinas Vol#: 156

C 6139 Deborah V Avalos Vol#: 156

C 6140 Craig Ramsey Vol#: 156

C 6141 Gwendolyn Hjelmstad Vol#: 156

C 6142 Gerald Dratch Vol#: 156

C 6143 Steve Arpin Vol#: 156

C 6144 Dianne F Lacock Vol#: 156

C 6145 Liz Claire Quey Vol#: 156

C 6146 Michael Richardson Vol#: 156

C 6147 Hollace Poole-Kavana Vol#: 156

C 6148 Alberta J Cassell-Butler Vol#: 156

C 6149 Kevin Graditor Vol#: 156

C 6150 Laingdon Schmitt Vol#: 156

C 6151 Form letter count 22 Vol#: 157

93V-0377 Laser Light Show

VRA 3 HFZ-300 Vol#: 1

95F-0065 Safe Use of polyamide-ethyleneimine-epichlorohydrin resin

REF 1 HFS-215 Vol#: 2

97N-0074 President's National Food Safety Initiative

C 122 Erin & Judy Marcus Vol#: 10

97P-0034 Establish std limits for lead in calcium supplements & Antac

PDN 1 HFC-1 to Altshuler, Berzon, Nussbaum etc Vol#: 1

97P-0233 Maintain current system establishing lead limits food & drug

LET 3 HFD-560 to CHPA Vol#: 1

PAV 1 HFC-1 to Council for Responsibile Nutrit Vol#: 1

97P-0341 Regulate cigars, little cigars, as nicotine delivery systems

C 2 Jon Baum Vol#: 1

97V-0081 Laser Light Show

VRA 2 HFZ-300 Vol#: 1

98D-0566 Registration of Veterinary Medicinal Products

GDL 4 GUIDANCE Vol#: 1

GDL 5 GUIDANCE Vol#: 1

GDL 6 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

98F-0749 Mthylacrylate-divinyl benzene glycol divinyl ether terpolyme

NFR 1 Vol#: 1

98N-0359 Program priorities/Center for Food Safety & Applied Nutritin

C 39 Safe Table Our Priority Vol#: 1

98N-0581 Requirements for Testing Human Blood Donors

C 4 Sacramento Medical Foundation Vol#: 5

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

C 4732 Wm H Evans Vol#: 135

98P-0145 Requirements for demonstrating In Vivo Bioequivalence

C 17 University of Missouri-Kansas City Vol#: 5

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

C 2285 Scott Douglas Vol#: 64

98P-0203 Eliminate Forced Molting of Laying Birds

C 1840 J D Davis Family Vol#: 45

C 1841 Ms Lois R Tomassetti Vol#: 45

C 1842 Suzann Gilmore Vol#: 45

C 1843 Mrs S Rosevear Vol#: 45

C 1844 Miss R J Poole Vol#: 45

C 1845 Natashia Tabler Vol#: 45

C 1846 K Kramer Vol#: 45

C 1847 Erin & Judy Marcus Vol#: 45

C 1848 Evelyn Thor Vol#: 45

C 1849 Voices for Animals Vol#: 45

C 1850 Paul E Toussaint Vol#: 45

C 1851 Kristy L Boeller Vol#: 45

C 1852 W Ron DeHaven Vol#: 45

EC 2 Brandon R Bensley Vol#: 45

98P-0624 Permit approval of ANDAs filed for ticlopidine hydrochloride

ANS 1 HFD-1 to Cohen, Pontani, Lieberman & Pav Vol#: 2

98P-0694 Determine Exclusivity date for Diltiazem Hydrichloride

PAV 1 HFD-1 to Keller & Heckman LLP Vol#: 1

98P-0821 Hydromorphone Hydrochloride Injection

PDN 1 HFD-600 to Abbott Laboratories Vol#: 1

99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 327 Kevin M Crupi Vol#: 16

99D-2636 Guidance for Industry on Levothyroxine Sodium

C 2 Forest Laboratories, Inc Vol#: 1

99D-4070 "Stability Testing: Photostability testing of New Veterinary

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

99D-4071 'Impurities: Residual Solvents.;

GDL 1 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

99H-0962 Civil Money Penalties;Phoug Nguyen,d/b/a Boston Street Varie

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-0967 Civil Money Penalties;Bay Tran,d/b/a Sunny Market

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1011 Civil Money Penalties;Carl White Oil Co Inc,d/b/a White Stat

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1042 Civil Money Penalties;Claudino Cardoso,d/b/a Hillside Deli

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1402 Civil Money Penalty; Larry's United Super Inc d/b/a Larry's

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-2859 Civil Money Penalty;Henderson Oil Company Inc,dba Energy Mar

MO 1 GCF-1 Vol#: 1

99N-1307 Preliminary Regulatory Impact Analysis and Initial Regulatoy

C 5 James G. Basler Vol#: 1

99N-1502 Quality Mammography Standards

N 1 Vol#: 1

99N-2151 New Animal Drug Applications; Sheep as a Minor Species

C 2 MSU Dept of Animal & Range Sciences Vol#: 1

C 3 American Farm Bureau Federation Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 1766 Kate Stamm Vol#: 163

99P-0792 Approval of Dosage Strengths

PAV 1 HFD-1 to Kleinfeld, Kaplan & Becker Vol#: 1

99P-1340 Declared Eternity eau de Parfum Misbranded

EC 51 Larry & Neva Bailey Vol#: 6

99P-1589 Stay effective date of approval for NDA 20-932 Roxicodone

RC 5 Roxane Laboratories, Inc Vol#: 1

99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease

Duplicates comments of 99P-3030 below

C 178 Julian Whitaker MD Vol#: 8

C 179 Chris G Arvanites Vol#: 8

C 180 Alfred Stevens Vol#: 8

C 181 Irene Cyson Vol#: 8

C 182 Robert & Marilyn Cargill Vol#: 8

C 183 Curtis & Beverly Randolph Vol#: 8

C 184 Michael G Hanna Vol#: 8

C 185 U S Nutraceuticals Vol#: 8

99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia

C 177 Julian Whitaker MD Vol#: 5

C 178 Chris G Arvanites Vol#: 5

C 179 Alfred Stevens Vol#: 5

C 180 Irene Cyson Vol#: 5

C 181 Robert & Marilyn Cargill Vol#: 5

C 182 Curtis & Beverly Randolph Vol#: 5

C 183 Michael G Hanna Vol#: 5

C 184 U S Nutraceuticals Vol#: 5

99V-0125 Laser Light Show Laserium CSMX250

VRA 1 HFZ-300 to Universal Studios Florida Vol#: 1

99V-0190 Variance Laser Light Show LSD110XL MRAK10 & MRAK250

VRA 1 HFZ-300 to Artistic Laser Productions Vol#: 1

99V-0294 Laser light show

VRA 1 HFZ-300 to Chakra Seven Vol#: 1

99V-0556 Medical Laser on display

LET 1 HFZ-343 to The Tech Museum of Innovation Vol#: 1

99V-1088 Laser Light Show, LaserXpress

VRA 1 HFZ-300 to Splash Entertainment Vol#: 1

99V-4463 Laser Light Show

ACK 1 HFA-305 Vol#: 1