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 28, 1999

Table of Contents

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

[FDA DOCKETS PAGE][FDA HOME PAGE]

 
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements *
91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement *
91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements *
91N-100H Health Claims & Label Statements; Folate & Neural Tube 
92N-0139 Statement Policy: Foods Derived from New Plant Varieties *
92V-0331 Laser Light Show *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97D-0318 Revised Precautionary Measure to Reduce Transmission of 
97P-0197 Require that warning labels about risks of salmonella enteri *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection) *
98D-0545 Recommendations/Collecting Red Blood Cells/Auto. Apheresis *
98N-0046 Comprehensive List of Current Guidance Documents at FDA *
98N-1215 Foreign Establishment Registration and Listing *
98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell *
98N-1265 Distribution of Compounded Drug Products *
99A-4659 Oxine(stabilized chlorine dioxide)*
99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices *
99D-2726 Labeling for laboratory tests*
99D-3082 E10- Choice of Control Group in Clinical Trials *
99M-4619 PMA Acticon Neosphincter, H990003*
99N-2151 New Animal Drug Applications; Sheep as a Minor Species *
99P-1266 Regulation minimum potency limit 90% dietary supplements *
99P-4208 Revise the Labeling Requir. for Foods Contain'g Sorbitol *
91N-0098 Dietary Fiber & Cancer, Health Claims & Label Statements

C 118 University Of Minnesota Vol#: 20

91N-0101 Antioxidant Vitamins & Cancer,Hlth. Claims & Label Statement

C 172 University Of Minnesota Vol#: 40

91N-0103 Fatty Acids & Heart Disease, Hlth.Claims & Label Statements

C 105 University Of Minnesota Vol#: 29

91N-100H Health Claims & Label Statements; Folate & Neural Tube Defec

C 97 University Of Minnesota Vol#: 11

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

C 6155 Ruth A Yacko Vol#: 156

C 6156 Karen Kieckhefer Vol#: 156

C 6157 Zena Lankiwich Vol#: 156

C 6158 Carol Pratt Vol#: 156

C 6159 Angela Lew Vol#: 156

C 6160 R Keller Vol#: 156

C 6161 Priscilla Trauner Vol#: 156

C 6162 Lara O'Connor Vol#: 156

C 6163 Mark Epstein & Edith Davidson Vol#: 156

C 6164 William J Baroch Vol#: 156

C 6165 Chama Archimede Vol#: 156

C 6166 Sarah Godlove Vol#: 156

C 6167 Sam Coffey Vol#: 156

C 6168 Kerry Shapleigh Vol#: 156

C 6169 Toni Drawier Vol#: 156

C 6170 Carol Davidson Vol#: 156

C 6171 Bob Buchmon Vol#: 156

C 6172 McDevitt Vol#: 156

C 6173 Jacqueline Davidson & Stuart Feldman Vol#: 156

C 6174 Janet A McKinnon Vol#: 156

C 6175 Kathryn Spielvogel Vol#: 156

C 6176 Andrew Huff Vol#: 156

C 6177 William Johnson Vol#: 156

C 6178 Greta Peck Vol#: 156

C 6179 John McKinnon Vol#: 156

C 6180 Judy Zemel Vol#: 156

C 6181 Shirley Cohen Vol#: 156

C 6182 George & Dorothy Minalga Vol#: 156

C 6183 Margaret M Stathos Vol#: 156

C 6184 Martin Washburn Vol#: 156

C 6185 Mark K Wexler Vol#: 156

C 6186 Gena M Dilabio Vol#: 156

C 6187 Cathleen M Brown Vol#: 156

C 6188 Peggy R Prichett Vol#: 156

C 6189 Cynthia Bagby Vol#: 156

C 6190 Kristin Lierheimer Vol#: 156

C 6191 Susan Farnham Vol#: 156

C 6192 Lillian Winston Vol#: 156

C 6193 Carla S White Vol#: 156

C 6194 Nancy L Knight Vol#: 156

C 6195 Betty Barfield Vol#: 156

C 6196 B S Golosman Vol#: 156

C 6197 Form letter count 48 Vol#: 158

92V-0331 Laser Light Show

EXP 3 Advanced Entertainment Technologies Vol#: 1

95F-0187 Safe Use of Poly[6-[(1,1,3,3-tetramethylbutyl)amino]

NWL 1 HFS-215 Vol#: 1

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

Linked comments below duplicate those for 97P-0197 and 98N-1230, also below

C 749 Bill Hickman Sr Vol#: 27

C 750 Ray Grimsinger Vol#: 27

C 751 Kathy Bissonette Vol#: 27

C 752 Robert W Springer Vol#: 27

97D-0318 Revised Precautionary Measure to Reduce Transmission of CJD

C 11 National Hemophilia Foundation Vol#: 1

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

C 750 Bill Hickman Sr Vol#: 26

C 751 Ray Grimsinger Vol#: 26

C 752 Kathy Bissonette Vol#: 26

C 753 Robert W Springer Vol#: 26

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

LET 4101 Nature's Way Products Inc Vol#: 28

LET 4102 Nature's Sunshine Products Inc Vol#: 28

LET 4103 Weider Nutrition International Inc Vol#: 28

LET 4104 Weider Nutrition International Inc Vol#: 28

LET 4105 Weider Nutrition International Inc Vol#: 28

LET 4106 Weider Nutrition International Inc Vol#: 28

LET 4107 Weider Nutrition International Inc Vol#: 28

LET 4108 Weider Nutrition International Inc Vol#: 28

LET 4109 Weider Nutrition International Inc Vol#: 28

LET 4110 Weider Nutrition International Inc Vol#: 28

LET 4111 Weider Nutrition International Inc Vol#: 28

LET 4112 Weider Nutrition International Inc Vol#: 28

LET 4113 Weider Nutrition International Inc Vol#: 28

LET 4114 Weider Nutrition International Inc Vol#: 28

LET 4115 Weider Nutrition International Inc Vol#: 28

LET 4116 Weider Nutrition International Inc Vol#: 28

LET 4117 Weider Nutrition International Inc Vol#: 28

LET 4118 Weider Nutrition International Inc Vol#: 28

LET 4119 Naturalife Corporation Vol#: 28

LET 4120 Naturalife Corporation Vol#: 28

LET 4121 Rexall Sundown Inc Vol#: 28

LET 4122 Rexall Sundown Inc Vol#: 28

LET 4123 Rexall Sundown Inc Vol#: 28

LET 4124 Rexall Sundown Inc Vol#: 28

LET 4125 Rexall Sundown Inc Vol#: 28

LET 4126 Rexall Sundown Inc Vol#: 28

LET 4127 Rexall Sundown Inc Vol#: 28

LET 4128 Rexall Sundown Inc Vol#: 28

LET 4129 Rexall Sundown Inc Vol#: 28

LET 4130 Rexall Sundown Inc Vol#: 28

LET 4131 Rexall Sundown Inc Vol#: 28

LET 4132 Rexall Sundown Inc Vol#: 28

LET 4133 Rexall Sundown Inc Vol#: 28

LET 4134 Rexall Sundown Inc Vol#: 28

LET 4135 Rexall Sundown Inc Vol#: 28

LET 4136 Rexall Sundown Inc Vol#: 28

LET 4137 Rexall Sundown Inc Vol#: 28

LET 4138 Rexall Sundown Inc Vol#: 28

LET 4139 Rexall Sundown Inc Vol#: 28

LET 4140 Rexall Sundown Inc Vol#: 28

LET 4141 Rexall Sundown Inc Vol#: 28

LET 4142 Rexall Sundown Inc Vol#: 28

LET 4143 Rexall Sundown Inc Vol#: 28

LET 4144 Rite Aid Corporation Vol#: 28

LET 4145 New Chapter Inc Vol#: 28

LET 4146 New Chapter Inc Vol#: 28

LET 4147 New Chapter Inc Vol#: 28

LET 4148 New Chapter Inc Vol#: 28

LET 4149 New Chapter Inc Vol#: 28

LET 4150 New Chapter Inc Vol#: 28

LET 4151 New Chapter Inc Vol#: 28

LET 4152 New Chapter Inc Vol#: 28

LET 4153 New Chapter Inc Vol#: 28

LET 4154 New Chapter Inc Vol#: 28

LET 4155 New Chapter Inc Vol#: 28

LET 4156 New Chapter Inc Vol#: 28

LET 4157 New Chapter Inc Vol#: 28

LET 4158 New Chapter Inc Vol#: 28

LET 4159 New Chapter Inc Vol#: 28

LET 4160 New Chapter Inc Vol#: 28

LET 4161 New Chapter Inc Vol#: 28

LET 4162 New Chapter Inc Vol#: 28

LET 4163 New Chapter Inc Vol#: 28

LET 4164 New Chapter Inc Vol#: 28

LET 4165 New Chapter Inc Vol#: 28

LET 4166 New Chapter Inc Vol#: 28

LET 4167 New Chapter Inc Vol#: 28

LET 4168 New Chapter Inc Vol#: 28

LET 4169 New Chapter Inc Vol#: 28

LET 4170 New Chapter Inc Vol#: 28

LET 4171 New Chapter Inc Vol#: 28

LET 4172 New Chapter Inc Vol#: 28

LET 4173 New Chapter Inc Vol#: 28

LET 4174 New Chapter Inc Vol#: 28

LET 4175 NBTY Inc Vol#: 28

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 297 HFS-456 to Terra life Health Products Co Vol#: 7

98D-0372 FDAMA Section 122 Radiopharmaceuticals

C 4 Institute for Clinical Pet Vol#: 1

98D-0545 Recommendations/Collecting Red Blood Cells/Auto. Apheresis

C 11 Blood Systems Inc Vol#: 1

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

C 63 Arthur & Margaret Walsh Vol#: 2

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

C 22400 Lance M Martin Vol#:

98N-0046 Comprehensive List of Current Guidance Documents at FDA

C 1 Buc & Beardsley Vol#: 1

98N-1215 Foreign Establishment Registration and Listing

C 34 Medical Choice Vol#: 1

C 35 Canadian Embassy Vol#: 1

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

C 749 Bill Hickman Sr Vol#: 30

C 750 Ray Grimsinger Vol#: 30

C 751 Kathy Bissonette Vol#: 30

C 752 Robert W Springer Vol#: 30

98N-1265 Distribution of Compounded Drug Products

C 6136 Interlakes Medical Center Vol#: 171

98S-1064 The Implementation (MRA) between the United States & Europea

NM 1 HFG-1 Vol#: 1

99A-4659 Oxine(stabilized chlorine dioxide)

ACK 1 HFA-305 Vol#: 1

99D-2406 Draft Guidance on VICH GL9 Good Clinical Practices

C 2 Animal Health Institute Vol#: 1

C 3 Association of Veterinary Biologics Co Vol#: 1

C 4 IDEXX Laboratories Inc Vol#: 1

C 5 MVP Laboratories Inc Vol#: 1

C 6 FEDESA Vol#: 1

C 7 British Assn of Research Quality Assuran Vol#: 1

C 8 European Agency for the Eval of Med Proc Vol#: 1

99D-2726 Labeling for laboratory tests

C 1 Beckman Coulter Inc Vol#:

99D-3082 E10- Choice of Control Group in Clinical Trials

C 1 USF Physicians Group Vol#: 1

99D-4488 Reducing microbial food safety hazards for sprouted seeds

NAD 1 HFS-306 Vol#: 1

99D-4489 Sampling & microbial testing of spent irrigation water

NAD 1 HFA-306 Vol#: 1

99H-0981 Civil Money Penalties;Gene F Yeang,d/b/a David's Food Center

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1037 Civil Money Penalties;Maria Flora,d/b/a Lindell Amoco

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1111 Civil Money Penalties;Mutual Highland Auto Inc,d/b/a Highlan

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1113 Civil Money Penalties;Wendy M Maxie,d/b/a Wendy's Grocery

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-1354 Civil Money Penalty; Newcomb Oil Co & John L Newcomb Jr d/b/

CS 1 HFA-305 Vol#: 1

IDF 1 HF-3 Vol#: 1

99H-4210 Civil Money Penalty; Circle K Stores Inc,dba Circle K / 76

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4211 Civil Money Penalty;Convenience Stores Inc,dba Warm Springs

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4212 Civil Money Penalty;Vic Cooper,dba Cooper Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4213 Civil Money Penalty;D A W Inc,dba Eaton Apothecary

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4214 Civil Money Penalty;Dairy Mart Convenience Stores Inc,dba

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4215 Civil Money Penalty;H C K Corp,dba Kim's Supermarket

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4216 Civil Money Penalty;Jamie W Howell Sr,dba Huckster's Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4217 Civil Money Penalty;Ron Johnson,dba ACA Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4218 Civil Money Penalty;Lone Pine Inc,dba Country Corner

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4219 Civil Money Penalty;Parham's Grocery Inc,dba Pharham's Amoco

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4220 Civil Money Penalty;Bob Parker,dba Norton's shell & Mini Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4221 Civil Money Penalty;Peter Zaimes Inc,dba Foodstop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4222 Civil Money Penalty;Pine Mountain Super-Valu Inc,dba Super

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4223 Civil Money Penalty;Robert Prebor,dba Circle Convenience Sto

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4224 Civil Money Penalty;Quad C Ent LLC,dba Le Bayou

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4225 Civil Money Penalty;Quiktrip Corp,dba Quiktrip #617

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4226 Civil Money Penalty;Jamie Reames,dba Kit's Mini Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4227 Civil Money Penalty;Sandy Point Ent Inc,dba Alligator River

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4228 Civil Money Penalty;Bruce Smith & Ineria Smith,dba Weston

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4229 Civil Money Penalty;Sub-Q Inc,dba Weston Richardson Drug

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4231 Civil Money Penalty;Thomson Trucking Inc,dba Amoco West

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4232 Civil Money Penalty;Glenn Toten,dba Discount Tobacco Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4233 Civil Money Penalty;Wade's Food Center Inc,dba Piggly Wiggly

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4259 Civil Money Penalty;Marsh Corp.& Joseph Marsh,dba Kwik Shop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4260 Civil Money Penalty;Reata Petroleum Corp,dba Total Quick Mar

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4261 Civil Money Penalty;Sinclair Oil Corp,dba Sinclair Marketing

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4262 Civil Money Penalty;Smoky Market & Deli LLC,dba Smoky Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4283 Civil Money Penalty;Elizabeth Lewis,dba Joan's Grocery & Ser

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4324 Civil Money Penalty;Jerry's Foods Inc,dba Jerry's Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4325 Civil Money Penalty;Brad Lanier Oil Co Inc,dba Homerun Foods

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4326 Civil Money Penalty;Circle K Stores Inc,dba Circle K #8888

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4327 Civil Money Penalty;Conoco Inc,dba Conoco #42091

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4353 Civil Money Penalty;Ajay Corp,dba 360 Express Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4354 Civil Money Penalty;Blue Sky Petroleum LLC,dba Blue Sky Exxo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4355 Civil Money Penalty;Boonsboro Produce Market Inc,dba Boonsbo

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4356 Civil Money Penalty;E-Z Stop Food Marts Inc,dba E-z Stop #1

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4357 Civil Money Penalty;John A Franks,dba J & P Service

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4358 Civil Money Penalty;Connie Hipps,dba Dude's Grocery Store

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4359 Civil Money Penalty;The Kubbard Inc,dba The Kubbard

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4360 Civil Money Penalty;Southern Retailers Inc,dba Fas Mart #66

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99M-4619 PMA Acticon Neosphincter, H990003

AAV 1 American Medical Systems Inc Vol#: 1

99N-1392 Agency Information Collection: State Enforcement Notificatio

NAL 1 HFA-250 Vol#: 1

SS 1 Supporting Statement Vol#: 1

99N-1393 State Petitions for Exemption from Preemption

NAL 1 HFA-250 Vol#:

SS 1 Supporting Statement Vol#: 1

99N-1522 Agency Information Collection: Temporary Maketing Permit App

NAL 1 HFA-250 Vol#: 1

SS 1 Supporting Statement Vol#: 1

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

C 5 American Sheep Industry Association Inc Vol#: 1

99N-2670 Antiviral Drugs Advisory Committee

BKG 1 Background material/open session Vol#: 2

99N-4397 Survey of Food Manufacturing Facilities/Year 2000 compliance

N 1 HFA-250 Vol#: 1

99P-1266 Regulation minimum potency limit 90% dietary supplements

PDN 1 HFC-1 to Capsugel Division Vol#: 1

99P-4208 Revise the Labeling Requir. for Foods Contain'g Sorbitol

C 1 Ray Breitenbach, MD. MS Vol#: 1