DOCKETS ENTERED on May 10, 1999
Updated as of 5:45 am, June 2, 1999. The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.
TABLE OF CONTENTS
(ONLY FOR HYBERLINKED
ITEMS)
92N-0139
Statement Policy: Foods Derived from New Plant Varieties
95S-0316
75-Day Premarket Notifications for New Dietary Ingredients
98D-1168
Industry on ANDA Impurities in Drug Products;
98N-0337
Over the counter human drugs labeling requirements
98N-1038 Irradiation
in the production, processing, &handling of food
98N-1109
Mercury Compounds in Drugs and Food
98N-1265
Distribution of Compounded Drug Products
98P-0151
Introduction Of Downed Cattle Into The Food Supply
98P-0683 Soy
Protein Containing Products
99P-1041
Temporary Marketing Permit Salad Dressing
92N-0139 Statement Policy: Foods Derived from New Plant Varieties
C 5251 Harriet L. Smith Vol#: 83
94S-0120 510K Substantially Equivalent List
LST 83 April 1999 510k Monthly Vol#: 20
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients
RPT 42 P&Y American Dietary Supplements Inc Vol#: 23
97D-0024 Medical Devices; Immunotoxicity Test Framework; Dft Guidance
GDL 2 Vol#: 1
NAD 2 Vol#: 1
98D-1168 Industry on ANDA Impurities in Drug Products;
98N-0337 Over the counter human drugs labeling requirements
C 1 Consumer Healthcare Products Assn Vol#: 2
98N-0811 Review for products in fast track drug development programs
N 3 Vol#: 1
98N-1038 Irradiation in the production, processing, &handling of food
C 1099 Christine M. Hoch Vol#: 24
C 1100 Christopher K. Neitzert Vol#: 24
C 1101 Michael S. Ford Vol#: 24
C 1104 Lisa Jurgensen Herman Vol#: 24
C 1105 Grace Marie Potorti Vol#: 24
C 1106 Denis E. Beller, Ph.D. Vol#: 24
C 1107 Daniel L. Nagengast Vol#: 24
C 1108 Michael C. Baker, Ph.D. Vol#: 24
C 1109 Patrick Schannong Vol#: 24
C 1111 David Zuckerman Vol#: 24
C 1112 Sheldon Nicholl Vol#: 24
C 1113 Joanne Bergstrom Vol#: 24
C 1116 Joan & John Kuveke Vol#: 24
C 1117 Sandra C. Glagola Vol#: 24
C 1119 Carole Anne Barnett Vol#: 24
C 1120 Gloria Bauermeister Vol#: 24
C 1121 Louanna Harris Vol#: 24
C 1123 Heather Kendon Vol#: 24
EXT 5 Ella Watson-Stryker Vol#: 24
98N-1109 Mercury Compounds in Drugs and Food
C 5 Newton Homeopatic Medicine Lab, Inc. Vol#: 2
98N-1265 Distribution of Compounded Drug Products
C 1819 Beverly Y. Robinson Vol#: 75
C 1820 Jack & Mary Jo Varah Vol#: 75
C 1821 Patricia J. Bean Vol#: 75
C 1822 Marle L. Burns Vol#: 75
C 1825 Karen C. Baechle Vol#: 75
C 1826 Jennifer Perry Vol#: 75
C 1829 Patricia Jankowski Vol#: 75
C 1831 Delores C. Norton Vol#: 75
C 1834 Allyson Linehon Vol#: 75
C 1835 Joan B. Gassiott Vol#: 75
C 1836 Elizabeth Pojar Vol#: 75
C 1838 Rossie A. Dunham Vol#: 75
C 1839 Michelle Weitzman Vol#: 75
C 1842 Janice J. Marshel Vol#: 75
C 1843 Gerry Jurgensen Vol#: 75
C 1848 Cassina Tarsia Vol#: 75
C 1852 Roberta Silvers Vol#: 75
C 1855 Betty B. Wisman Vol#: 75
C 1857 Linda G. Musfeldt Vol#: 75
C 1858 Starr/ McAlister Vol#: 75
C 1859 Jeannie Collins Vol#: 75
C 1865 Mary Eillioeger Vol#: 75
C 1867 Mary Hutchinson Vol#: 75
C 1869 Carole Giovacchini Vol#: 75
C 1871 Rochelle A. Hover Vol#: 75
98P-0151 Introduction Of Downed Cattle Into The Food Supply
C 2143 David E. Johnson Vol#: 52
C 2144 Jane Cammarata Vol#: 52
98P-0683 Soy Protein Containing Products
C 130 Pacific Soybean & Grain Vol#: 19
99F-1170 Stabilizer for Repeat Use of Rubber Articles
NFL 1 Ciba Specialty Chemicals Corp. Vol#: 1
99H-0810 Civil Money Penalties;Hawk II Environmental Corp,d/b/a Joe
ANS 1 Hawk II Environmental Corp Vol#: 1
99H-0822 Civil Money Penalties;Mubeen Mahmood,d/b/a Shell Gas Station
ANS 1 Mubeen Ineternational Vol#: 1
99H-0889 Civil Money Penalties;Rodney W Ray,d/ba/ Rod's Convenience
ANS 1 Rod's Convenience Vol#: 1
99H-1222 Civil Money Penalties;Delchamps Inc,d/b/a Jitney Jungle #328
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1223 Civil Money Penalties;East Coast Oil Corp,d/b/a East Coast
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1224 Civil Mone Penalties;Kmart Corp,d/b/a Kmart Store #9520
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1225 Civil Money Penalties;Dennis Remington,d/b/a Wells Chevron
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1226 Civil Money Penalties;Smith Food & Drug Ctrs Inc,d/b/a Smith
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1227 Civil Money Penalties;Robert Tennie,d/b/a 16th Ave Shell
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1229 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99H-1230 Civil Money Penalties;Numa F Young,d/b/a Young's Super Marke
LET 1 Office of Tobacco Programs Vol#: 1
NPH 1 HHS/FDA/CDER Vol#: 1
99N-1010 Investigational New Drug Regulations
N 1 Vol#: 1
99N-1069 Changes in Procedures for Providing Public Notice
NAD 1 Vol#: 1
99P-1041 Temporary Marketing Permit Salad Dressing
CP 1 Kraft Foods, Inc. Vol#: 1
LET 1 Kraft Foods, Inc. Vol#: 1
LET 2 Kraft Foods, Inc. Vol#: 1
LET 3 Kraft Foods, Inc. Vol#: 1
NTP 1 Vol#: 1